Understanding Cancer FDA Updates

Recent Approvals from the U.S. Food and Drug Administration

Darzalex Approved to Treat People with Multiple Myeloma Who Are Ineligible for Autologous Stem Cell Transplant
The U.S. Food and Drug Administration has approved Janssen Biotech’s Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for people with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Approval was based on a phase III study comparing Darzalex in combination with lenalidomide and low-dose dexamethasone to lenalidomide and low-dose dexamethasone alone. The trial demonstrated an improvement in progression-free survival in trial participants receiving Darzalex in combination with lenalidomide and low-dose dexamethasone, compared with those receiving only lenalidomide and low-dose dexamethasone. 

This application used the Real-Time Oncology Review. FDA also granted this application priority review.


FDA Grants Accelerated Approval to Xpovio for Multiple Myeloma
Karyopharm Therapeutics’ Xpovio (selinexor) in combination with dexamethasone has been granted accelerated approval to treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

Efficacy was evaluated in an open-label study of 122 people with relapsed or refractory multiple myeloma who had previously received three or more anti-myeloma treatment regimens including an alkylating agent, glucocorticoids, bortezomib, carfilzomib, lenalidomide, pomalidomide, and an anti-CD38 monoclonal antibody. The approval was based on efficacy and safety in a prespecified subgroup analysis of 83 people whose disease was refractory to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab. 

As a condition of accelerated approval, further clinical trials may be required to verify and describe Xpovio’s benefit. The FDA also granted this application fast track designation and orphan drug designation. 


FDA Approves Nubeqa for Non-Metastatic Castration-Resistant Prostate Cancer
Nubeqa (darolutamide), which is marketed by Bayer HealthCare Pharmaceuticals, has been approved by the FDA for the treatment of non-metastatic castration-resistant prostate cancer.

Approval was based on a placebo-controlled clinical trial in which the primary endpoint was metastasis-free survival. The median metastasis-free survival was 40.4 months for participants treated with Nubeqa, compared with 18.4 months for those receiving placebo.

The FDA granted Nubeqa fast track designation, in addition to granting this application priority review. 


Keytruda Approved to Treat Advanced Esophageal Squamous Cell Cancer
The FDA has approved Merck’s Keytruda (pembrolizumab) for people with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus whose tumors express PD-L1, as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy. The FDA also approved a new use for the PD-L1 IHC 22C3 pharmDx kit as a companion diagnostic device for selecting people for the above indication.

Efficacy was investigated in two clinical trials: one measuring overall survival and one measuring overall response rate and response duration. The FDA granted these applications priority review. 

FDA Approves Turalio as Treatment for Tenosynovial Giant Cell Tumor
Turalio (pexidartinib) capsules have been granted FDA approval for adults with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery. Turalio, which is marketed by Daiichi Sankyo, is the first systemic therapy approved for people with tenosynovial giant cell tumor.

The FDA granted Turalio breakthrough therapy and orphan drug designation, in addition to granting this application priority review. 


FDA Approves First Chemoimmunotherapy Regimen for People with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (a combination known as “BR”), has been granted accelerated approval by the U.S. Food and Drug Administration to treat adults with diffuse large B-cell lymphoma that has progressed or returned after at least two prior therapies. Polivy, which is marketed by Genentech, is a novel antibody-drug conjugate, and diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma.

“Antibody-drug conjugates are an emerging class of targeted immunotherapies for cancer. This type of therapy, unlike traditional chemotherapy, is intended to target specific cells,” says Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “[This] approval of Polivy provides an alternative option for patients in whom multiple treatments have not worked.”

Polivy in combination with BR was granted accelerated approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need based on an endpoint that is reasonably likely to predict a clinical benefit to people taking the drug. Further clinical trials are required to verify and describe Polivy’s clinical benefit. The FDA granted this application breakthrough therapy and priority review designations. Polivy also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. 

Keytruda Approved for First-Line Treatment of Head and Neck Squamous Cell Carcinoma
The FDA has approved Merck’s Keytruda (pembrolizumab) for the first-line treatment of people with metastatic or unresectable recurrent head and neck squamous cell carcinoma. Keytruda was approved for use in combination with platinum and fluorouracil (FU) for all patients and as a single agent for those whose tumors express PD‑L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA‑approved test. The FDA also expanded the intended use for the PD-L1 IHC 22C3 pharmDx kit to include use as a companion diagnostic device for selecting people with head and neck squamous cell carcinoma for treatment with Keytruda as a single agent.

FDA Grants Approval to Keytruda for Metastatic Small Cell Lung Cancer
The FDA has granted accelerated approval to Merck’s Keytruda (pembrolizumab) for the treatment people with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

Revlimid Approved to Treat Follicular and Marginal Zone Lymphoma
The FDA has granted approval to Celgene’s Revlimid (lenalidomide) in combination with a rituximab product for previously treated follicular lymphoma and previously treated marginal zone lymphoma.

FDA Approves Tibsovo As First-Line Treatment for AML with IDH1 Mutation
The U.S. Food and Drug Administration has approved Agios Pharmaceuticals’ Tibsovo (ivosidenib) for newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation, as detected by an FDA-approved test, in people who are at least 75 years old or who have additional medical conditions that prohibit the use of intensive induction chemotherapy.

Approval was based on a multicenter clinical trial of single-agent Tibsovo for newly diagnosed AML with an IDH1 mutation detected by the Abbott RealTimeTM IDH1 Assay. Twelve of the 28 participants enrolled in the trial achieved remission, and 7 of the 17 transfusion-dependent survivors achieved transfusion independence lasting at least 8 weeks.

This application used the Real-Time Oncology Review pilot program. In addition, the FDA granted this application priority review and orphan product designation. 

Kadcyla Approved as Treatment for Early Breast Cancer
Kadcyla (ado-trastuzumab emtansine) has been granted FDA approval for the adjuvant treatment of people with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

Breast cancer survivors should be selected for treatment with Kadcyla based on an FDA-approved companion diagnostic. The FDA also approved the Pathway anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody assay and the Inform HER2 Dual ISH DNA Probe Cocktail assay, which are both marketed by Ventana Medical Systems, as companion diagnostic devices for selecting people eligible for treatment with Kadcyla.

This application used the Real-Time Oncology Review and Assessment Aid pilot programs. The FDA also granted this application priority review. In addition, Kadcyla, which is marketed by Genentech, was granted breakthrough therapy designation for the adjuvant treatment of people with HER2-positive early breast cancer who have residual disease after preoperative systemic treatment. 

Cyramza Gains FDA Approval as Hepatocellular Carcinoma Treatment
The FDA has approved Eli Lilly’s Cyramza (ramucirumab) as a single agent for treating hepatocellular carcinoma in people who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL and who have been previously treated with sorafenib.

Approval was based on a multinational, randomized, double-blind, placebo-controlled, multicenter study in 292 people with advanced hepatocellular carcinoma with AFP ≥ 400 ng/mL who had disease progression on or after sorafenib or who were intolerant. The estimated median overall survival was 8.5 months for people receiving Cyramza and 7.3 months for those receiving placebo.

FDA Approves Bavencio Plus Axitinib for Renal Cell Carcinoma
The FDA has granted approval to EMD Serono’s Bavencio (avelumab)in combination with axitinib for first-line treatment of people with advanced renal cell carcinoma.

Approval was based on a randomized, multicenter trial of Bavencio plus axitinib in 886 people with untreated advanced renal cell carcinoma. Participants receiving this combination showed a statistically significant improvement in progression-free survival. 

This application used the Assessment Aid pilot program. In addition, the FDA granted this application priority review and breakthrough therapy designation. 

Venclexta Approved to Treat CLL and SLL
AbbVie and Genentech’s Venclexta (venetoclax) has been granted FDA approval for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The FDA used the Real-Time Oncology Review and Assessment Aid pilot programs for this application and granted priority review as well as orphan drug and breakthrough therapy designations.

FDA Approves Jakafi for Acute Graft-Versus-Host Disease
The FDA has granted approval to Incyte Corporation’s Jakafi (ruxolitinib) for steroid-refractory acute graft-versus-host disease (GVHD) in adults and adolescents age 12 years and older. The FDA granted this application priority review. 

FDA Grants Approval to First PI3K Inhibitor for Breast Cancer 
The FDA has approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (as detected by an FDA-approved test) following progression on or after an endocrine-based regimen.

The FDA also approved a companion diagnostic test, therascreen PIK3CA RGQ PCR Kit, to detect the PIK3CA mutation in a tissue and/or a liquid biopsy. People who are negative by the therascreen test using the liquid biopsy should undergo tumor biopsy for PIK3CA mutation testing.

“Piqray is the first PI3K inhibitor to demonstrate a clinically meaningful benefit in treating patients with this type of breast cancer. The ability to target treatment to a patient’s specific genetic mutation or biomarker is becoming increasingly common in cancer treatment, and companion diagnostic tests assist oncologists in selecting patients who may benefit from these targeted treatments,” says Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For this approval, we employed some of our newer regulatory tools to streamline reviews without compromising the quality of our assessment. This drug is the first novel drug approved under the Real-Time Oncology Review pilot program. We also used the updated Assessment Aid, a multidisciplinary review template that helps focus our written review on critical thinking and consistency and reduces time spent on administrative tasks.”

The FDA also granted this application priority review designation. The FDA granted approval of Piqray to Novartis and approval of the therascreen PIK3CA RGQ PCR Kit to Qiagen Manchester, Ltd.

Keytruda Plus Axitinib Approved to Treat Advanced Renal Cell Carcinoma
The U.S. Food and Drug Administration has approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of people with advanced renal cell carcinoma. The approval is based on findings from a phase III trial which demonstrated significant improvements in overall survival, progression-free survival, and objective response rate for Keytruda in combination with axitinib compared to sunitinib. The FDA granted this application Priority Review and Breakthrough Therapy designation. 

FDA Approves First Targeted Therapy for Metastatic Bladder Cancer
The FDA has granted accelerated approval to Balversa (erdafitinib), a treatment for adults with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. People should be selected for therapy with Balversa using an FDA-approved companion diagnostic device.

“We’re in an era of more personalized or precision medicine, and the ability to target cancer treatment to a patient’s specific genetic mutation or biomarker is becoming the standard, with advances being made in new disease types. [This] approval represents the first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer,” says Richard Pazdur, md, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. 

Balversa received an Accelerated Approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit. Further clinical trials are required to confirm Balversa’s clinical benefit. Balversa was also granted Breakthrough Therapy designation. The FDA granted the approval of Balversa to Janssen Pharmaceutical.

The FDA also approved the therascreen FGFR RGQ RT-PCR Kit, developed by Qiagen Manchester, Ltd., for use as a companion diagnostic with Balversa for this therapeutic indication.

FDA Expands Keytruda Indication for First-Line Treatment of Non-Small Cell Lung Cancer 
The FDA has approved an expanded label for Merck’s Keytruda (pembrolizumab) as monotherapy for the first-line treatment of people with stage III non-small cell lung cancer who are not candidates for surgical resection or definitive chemoradiation, or metastatic non-small cell lung cancer, and whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

Keytruda, which is marketed by Merck, was previously approved as a single agent for the first-line treatment of people with metastatic non-small cell lung cancer whose tumors express PD-L1 TPS ≥50%.

Ibrance Approved to Treat Men with HR+, HER2- Metastatic Breast Cancer
The FDA has approved a supplemental New Drug Application to expand the indications for Pfizer’s Ibrance (palbociclib) in combination with an aromatase inhibitor or fulvestrant to include men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. The approval is based on data from electronic health records and postmarketing reports of the real-world use of Ibrance in men with breast cancer. 

“With this approval, we are now able to offer IBRANCE to the underserved male breast cancer community and provide more patients with HR+, HER2- metastatic breast cancer the opportunity to access an innovative medicine,” says Chris Boshoff, MD, PhD, chief development officer for oncology at Pfizer Global Product Development.

FDA Approves Tecentriq for PD-L1 Positive Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer
The FDA has granted accelerated approval to Genentech’s Tecentriq (atezolizumab) in combination with paclitaxel protein-bound for adults with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test. The FDA also approved the VENTANA PD-L1 (SP142) Assay as a companion diagnostic device for selecting people with triple-negative breast cancer as candidates for Tecentriq. 

This indication for Tecentriq is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Tecentriq in Combination with Chemotherapy Receives FDA Approval for the Initial Treatment of Adults with Extensive-Stage Small Cell Lung Cancer
Tecentriq (atezolizumab), in combination with carboplatin and etoposide, has been granted FDA approval for the initial treatment of adults with extensive-stage small cell lung cancer. This approval is based on results from a phase III study which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone. 

“Tecentriq is the first cancer immunotherapy approved for the initial treatment of extensive-stage small cell lung cancer, which is especially difficult to treat,” says Sandra Horning, md, chief medical officer and head of Global Product Development at Genentech. “Until now, there have been limited treatment advances for this disease, and we are excited to bring a potential new standard of care to patients that has been shown to improve survival compared to chemotherapy.”

Tecentriq, which is marketed by Genentech, is also approved in combination with bevacizumab, paclitaxel, and carboplatin for the initial treatment of adults with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. Additionally, Tecentriq is approved by the FDA to treat adults with metastatic non-small cell lung cancer who have disease progression during or following platinum-containing chemotherapy. 

Cabometyx Approved to Treat Hepatocellular Carcinoma
The U.S. Food and Drug Administration has approved Cabometyx (cabozantinib) tablets for people with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. 

The FDA’s approval of Cabometyx was based on results from a phase III trial of Cabometyx for people with advanced hepatocellular carcinoma who received prior sorafenib. The results showed that Cabometyx demonstrated a statistically significant and clinically meaningful improvement in overall survival versus placebo. Cabometyx, which is a kinase inhibitor marketed by Exelixis, is also approved for the treatment of people with advanced renal cell carcinoma.

FDA Approves Keytruda for Adjuvant Treatment of Melanoma
Keytruda (pembrolizumab) has been granted FDA approval for the adjuvant treatment of people with melanoma with involvement of lymph nodes following complete resection. In a phase III trial, Keytruda – an anti-PD-1 therapy marketed by Merck – significantly prolonged recurrence-free survival, reducing the risk of disease recurrence or death by 43 percent compared to placebo in people with resected, high-risk stage III melanoma. 

Lonsurf Gains FDA Approval for Recurrent, Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
The FDA has approved Taiho’s Lonsurf (trifluridine/tipiracil) as a treatment for adults with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. Lonsurf tablets are a fixed combination of trifluridine, which is a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor. 

The approval for Lonsurf follows an FDA Priority Review designation and is based on data from a phase III trial evaluating Lonsurf plus best supportive care versus placebo plus best supportive care in people with previously treated advanced gastric cancer or GEJ adenocarcinoma following progression or intolerance to previous lines of standard therapy. The trial met its primary and secondary endpoints demonstrating prolonged overall survival with Lonsurf versus placebo.

FDA Approves New Formulation of Herceptin for Injection
Genentech’s Herceptin Hylecta (trastuzumab and hyaluronidase-oysk injection) has been approved by the FDA for subcutaneous (under the skin) injection for the treatment of HER2‑overexpressing breast cancer. This new treatment includes the same monoclonal antibody as intravenous Herceptin (trastuzumab) in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab under the skin. Herceptin Hylecta is a ready-to-use formulation that can be administered in two to five minutes, compared to 30 to 90 minutes for intravenous Herceptin.

New Drug Regimen for Acute Lymphoblastic Leukemia Gains FDA Approval
The FDA has approved Servier Pharmaceuticals’ Asparlas (calaspargase pegol-mknl) – an asparagine specific enzyme – as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia (ALL) in young adults and children ages 1 month to 21 years. This new product provides for a longer interval between doses compared to other available pegaspargase products.

Lynparza Approved as First-Line Maintenance Treatment for BRCA-Mutated Advanced Ovarian Cancer

The U.S. Food and Drug Administration has approved AstraZeneca’s Lynparza (olaparib) for the maintenance treatment of adults with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. People with germline BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer should be selected for therapy based on an FDA-approved companion diagnostic. The FDA also approved the BRACAnalysis CDx test, which is manufactured by Myriad Genetic Laboratories, to identify people who are eligible for Lynparza. 

Tecentriq in Combination Approved as First-Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer 
The FDA has approved Genentech’s Tecentriq (atezolizumab), in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of people with metastatic non-squamous, non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. Tecentriq, a programmed death-ligand 1 (PD-L1) blocking antibody, is also approved for the treatment of people with metastatic non-small cell lung cancer who have disease progression during or following platinum-containing chemotherapy. 

FDA Approves New Treatment for Adults with Relapsed or Refractory Acute Myeloid Leukemia with a Certain Genetic Mutation
The FDA has approved Astellas Pharma’s Xospata (gilteritinib) tablets for the treatment of adults who have relapsed or refractory acute myeloid leukemia with a FLT3 mutation as detected by an FDA-approved test. The FDA also approved an expanded indication for a companion diagnostic to be used with Xospata. The LeukoStrat CDx FLT3 Mutation Assay, developed by Invivoscribe Technologies, is used to detect the FLT3 mutation in people with AML.

“Approximately 25 to 30 percent of patients with AML have a mutation in the FLT3 gene. These mutations are associated with a particularly aggressive form of the disease and a higher risk of relapse,” says Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Xospata targets this gene and is the first drug to be approved that can be used alone in treating patients with AML having a FLT3 mutation who have relapsed or who don’t respond to initial treatment.”

FDA Approves Oncology Drug That Targets a Key Genetic Driver of Cancer, Rather Than a Specific Type of Tumor
The FDA has granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric cancer survivors whose cancers have a specific genetic feature, or biomarker. This is the second time the agency has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated. The approval marks a new paradigm in the development of cancer drugs that are “tissue agnostic.” 

Vitrakvi, which is manufactured by Loxo Oncology, is indicated for the treatment of adult and pediatric cancer survivors with solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

“[This] approval marks another step in an important shift toward treating cancers based on their tumor genetics rather than their site of origin in the body,” says FDA Commissioner Scott Gottlieb, MD. “This new site-agnostic oncology therapy isn’t specific to a cancer arising in a particular body organ, such as breast or colon cancer. Its approval reflects advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine. We now have the ability to make sure that the right patients get the right treatment at the right time.” 

New AML Treatment Gains FDA Approval
The FDA has approved Pfizer’s Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine, a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia in adults who are 75 years of age or older or who have other chronic health conditions or diseases that may preclude the use of intensive chemotherapy. Almost half of the adults diagnosed with AML are not treated with intensive chemotherapy because of comorbidities and chemotherapy-related toxicities.

Venclexta in Combination Approved as AML Treatment 
Venclexta (venetoclax), in combination with azacitidine or decitabine or low-dose cytarabine, has been granted accelerated approval for the treatment of newly-diagnosed acute myeloid leukemia in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Since this indication for Venclexta, which is marketed by AbbVie Inc. and Genentech, is approved under accelerated approval, further studies are required for continued approval. 

First Biosimilar for Treatment of Adults with Non-Hodgkin Lymphoma Gains FDA Approval
Truxima (rituximab-abbs) has been granted FDA approval as the first biosimilar to Genentech’s Rituxan (rituximab) for the treatment of adults with CD20-positive, B-cell non-Hodgkin lymphoma. It is to be used as a single agent or in combination with chemotherapy. Truxima, which is manufactured by Celltrion, is the first biosimilar to be approved in the U.S. for the treatment of non-Hodgkin lymphoma.

Truxima has been approved as a biosimilar, not as an interchangeable product. A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA and has no clinically meaningful differences in terms of safety, purity, and potency from the reference product, in addition to meeting other criteria specified by law. With the Truxima approval, the FDA has approved 15 biosimilars.

FDA Grants Accelerated Approval to Keytruda for Hepatocellular Carcinoma
The U.S. Food and Drug Administration has granted accelerated approval to Merck’s Keytruda (pembrolizumab) for people with hepatocellular carcinoma who have been previously treated with sorafenib. As a condition of accelerated approval, further studies are required. 

FDA Approves First-Line Treatment for Peripheral T-Cell Lymphoma Under New Review Pilot
The FDA has expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adults with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

“The Real-Time Oncology Review (RTOR) program allows the FDA to access key data prior to the official submission of the application allowing the review team to begin their review earlier and communicate with the sponsor prior to the application’s actual submission,” says Richard Pazdur, md, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products. “When the sponsor submits the completed application, the review team will already be familiar with the data and be able to conduct a more efficient, timely, and thorough review. RTOR allowed the FDA to approve this indication within two weeks of the completed application’s submission.”

Adcetris, which is manufactured by Seattle Genetics, is a monoclonal antibody that binds to a protein (called CD30) found on some cancer cells. Adcetris is now approved to treat previously untreated systemic anaplastic large cell lymphoma and other CD30-expressing PTCLs in combination with chemotherapy. 

Lorbrena Approved to Treat ALK-Positive Metastatic Non-Small Cell Lung Cancer 
Pfizer’s Lorbrena (lorlatinib) has been granted accelerated approval to treat people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 

Keytruda in Combination with Chemotherapy Gains Approval as First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer 
The FDA has approved Merck’s Keytruda (pembrolizumab) in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer. The FDA granted this application priority review.

FDA Approves Herzuma as a Biosimilar to Herceptin
Celltrion’s Herzuma (trastuzumab-pkrb) has been approved by the FDA as a biosimilar to Genentech’s Herceptin (trastuzumab) for people with HER2-overexpressing breast cancer. Herzuma is a HER2/neu receptor antagonist indicated for the treatment of HER2-overexpressing breast cancer. Herzuma has been approved as a biosimilar, not as an interchangeable product.