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FDA NEWS: April 13, 2021 to May 21, 2021

TON - June 2021 Vol 14, No 3 - FDA Updates

This section provides a brief overview of new cancer drugs and new indications approved by the FDA between April 13, 2021, and May 21, 2021.


NEW DRUGS

FDA Approves Rybrevant, First Targeted Therapy for Patients with NSCLC and EGFR Exon 20 Insertion Mutations

On May 21, 2021, the FDA approved amivantamab-vmjw (Rybrevant; Janssen), an epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor bispecific antibody, for the treatment of patients with locally advanced or metastatic non–small-cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The FDA granted amivantamab priority review and a breakthrough therapy designation for this indication.

“Advances in precision oncology continue to facilitate drug development, allowing diseases like lung cancer to be subset into biomarker-defined populations appropriate for targeted therapies,” said Julia Beaver, MD, Chief of Medical Oncology in the FDA’s Oncology Center of Excellence. “With today’s approval, for the first time, patients with non-small cell lung cancer with EGFR exon 20 insertion mutations will have a targeted treatment option.”

The FDA simultaneously approved the Guardant360 (Guardant Health) CDx liquid biopsy blood test as a companion diagnostic for use with amivantamab.

The FDA approval of amivantamab was based on results from a single-arm clinical trial that included 81 patients with NSCLC and EGFR exon 20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy. In the trial population in which all patients received amivantamab, the overall response rate (ORR) was 40%. The median duration of response was 11.1 months, with 63% of patients having a duration of response of ≥6 months.

The most common (≥20%) adverse reactions among patients treated with amivantamab included rash, infusion-related reactions, paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation, vomiting, and changes in certain blood tests.

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FDA Approves Zynlonta for Relapsed or Refractory Large B-Cell Lymphoma

On April 23, 2021, the FDA approved loncastuximab tesirine-lpyl (Zynlonta; ADC Therapeutics), a CD19-directed antibody–drug conjugate for the treatment of adults with relapsed or refractory large B-cell

lymphoma after ≥2 lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. The FDA granted loncastuximab tesirine priority review and an orphan drug designation for this indication.

The FDA approval of loncastuximab tesirine was based on results from the multicenter, open-label, single-arm, phase 2 LOTIS-2 clinical trial of 145 patients with relapsed or refractory DLBCL who had received ≥2 lines of previous systemic therapy. Patients received intravenous loncastuximab tesirine 0.15 mg/kg every 3 weeks for 2 cycles, followed by 0.075 mg/kg every 3 weeks for subsequent cycles, until progressive disease or unacceptable toxicity.

The ORR was 48.3% (95% confidence interval [CI], 39.9-56.7) with a complete response rate of 24.1% (95% CI, 17.4-31.9). After a median follow-up of 7.3 months, median response duration was 10.3 months (95% CI, 6.9-not evaluable).

The most common (≥20%) adverse reactions, including laboratory abnormalities, were thrombocytopenia, increased gamma-glutamyltransferase, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea, and musculoskeletal pain.

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Jemperli Approved for Patients with Recurrent or Advanced dMMR Endometrial Cancer

On April 22, 2021, the FDA approved dostarlimab-gxly (Jemperli; GlaxoSmithKline), a PD-1 inhibitor, for the treatment of adults with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a previous platinum-containing regimen. The FDA granted dostarlimab priority review and a breakthrough therapy designation for this indication.

“Today’s approval of Jemperli is evidence of the FDA’s progress in applying precision medicine to expand treatment options for patients with cancer,” said Richard Pazdur, MD, FDA’s Director of Oncology Center of Excellence. “This immunotherapy was specifically studied to target dMMR endometrial cancer and leverages scientific knowledge surrounding the mechanism of immunotherapy response in this unmet medical need population.”

The FDA approval was based on results from the dMMR endometrial cancer cohort of the ongoing multicenter, open-label, multicohort phase 1 GARNET clinical trial (N = 444). Patients in the trial received intravenous dostarlimab 500 mg once every 3 weeks for 4 doses, followed by 1000 mg once every 6 weeks until disease progression or unacceptable toxicity.

Among the 71 patients with dMMR advanced or recurrent endometrial cancer who received dostarlimab in the trial, the ORR was 42.3% (12.7% complete response rate and 29.6% partial response rate). For 93% of responders, responses lasted ≥6 months.

A total of 104 patients were evaluated for safety. The most common (≥20%) adverse reactions were fatigue/asthenia, nausea, diarrhea, anemia, and constipation. The most common (≥2%) grade 3 or 4 adverse reactions were anemia and increased transaminase. Serious adverse reactions occurred in 34% of patients receiving dostarlimab. Serious adverse reactions in >2% of patients included sepsis, acute kidney injury, urinary tract infection, abdominal pain, and pyrexia.

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NEW INDICATIONS

Opdivo Now Approved in Combination with Chemotherapy for Advanced or Metastatic Gastric Cancer

On April 16, 2021, the FDA approved nivolumab (Opdivo; Bristol Myers Squibb), a PD-1 inhibitor, in combination with certain types of chemotherapy, for the initial treatment of adults with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. The FDA granted nivolumab priority review and an orphan drug designation for this indication. Nivolumab has been previously approved by the FDA, alone or in combination with other therapies, for the treatment of many types of malignancies, including lung, colorectal, liver, melanoma, urothelial, and head and neck cancers, as well as for classical Hodgkin lymphoma.

“Today’s approval is the first treatment in more than a decade to show a survival benefit for patients with advanced or metastatic gastric cancer who are being treated for the first time,” said Richard Pazdur, MD, FDA’s Director of Oncology Center of Excellence. “The FDA is committed to bringing new safe and effective treatment options like Opdivo to patients with advanced cancer.”

The FDA approved this new indication based on results from the phase 3 CheckMate-649 clinical trial, which evaluated nivolumab in combination with fluorouracil, leucovorin, and oxaliplatin or capecitabine and oxaliplatin. Median survival was 13.8 months for patients who received nivolumab plus chemotherapy versus 11.6 months for patients who received chemotherapy alone.

The most common (≥20%) adverse reactions reported in the nivolumab plus chemotherapy arm included peripheral neuropathy (53%), nausea (48%), fatigue (44%), diarrhea (39%), vomiting (31%), decreased appetite (29%), abdominal pain (27%), constipation (25%), and musculoskeletal pain (20%).

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FDA Approves Trodelvy for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer

On April 13, 2021, the FDA granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy; Gilead Sciences/Immunomedics) for the treatment of adults with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor. The FDA granted sacituzumab govitecan priority review and a fast-track designation for this indication.

“Only a fraction of patients derives long-term benefit from previously approved cytotoxic therapy or immunotherapy, leaving a great unmet need for treatment options for patients with advanced urothelial cancer who have progressed on first- and second-line therapies,” said Scott T. Tagawa, MD, MS, FACP, Professor of Medicine and Urology at Weill Cornell Medical Center and principal investigator of the study, in a press release. “The response rate and tolerability seen with sacituzumab govitecan-hziy may provide physicians an effective new treatment option for patients whose cancer continues to progress even after multiple therapies.”

The FDA approved this indication based in part on results from the single-arm, multicenter TROPHY trial, which included 112 patients with locally advanced or metastatic urothelial carcinoma who previously received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. Patients received intravenous sacituzumab govitecan 10 mg/kg on days 1 and 8 of a 21-day treatment cycle.

The confirmed ORR was 27.7% (95% CI, 19.6-36.9), which included a 5.4% complete response rate and 22.3% partial response rate. The median duration of response among 31 responding patients was 7.2 months (95% CI, 4.7-8.6).

The most common (≥25%) adverse reactions among patients treated with sacituzumab govitecan included neutropenia, nausea, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, decreased appetite, rash, and abdominal pain.

Sacituzumab govitecan was granted accelerated approval on April 22, 2020, for the treatment of patients with metastatic triple-negative breast cancer who have received ≥2 previous therapies for metastatic disease. On April 7, 2021, the FDA granted full approval for this indication.

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Last modified: July 22, 2021