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FDA grants priority review to three oncology therapies
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The FDA granted priority review to three drugs in development for oncology indications.
The designations apply to use of:
• Pembrolizumab (Keytruda, Merck) monotherapy for third-line treatment of patients with advanced small cell lung cancer whose disease progressed after two or more lines of therapy.
The FDA based the designation on data from the phase 2 KEYNOTE-158 and phase 1b KEYNOTE-028 trials. Merck’s supplemental biologics license application seeks accelerated approval, and the FDA is expected to make a decision by June 17.
This is the first U.S. application for pembrolizumab, an anti-PD-1 therapy, for a small cell lung cancer indication.
“There is a significant need for new treatment options for small cell lung cancer, which has a 5-year survival rate of only 6% overall,” Jonathan Cheng, MD, vice president for oncology clinical research at Merck Research Laboratories, said in a company-issued press release. “Keytruda has already been established as an important treatment option for many patients with advanced non-small cell lung cancer and this acceptance provides an opportunity to potentially benefit even more patients.”
• Polatuzumab vedotin (Genentech) in combination with bendamustine plus rituximab (Rituxan; Genentech, Biogen) for relapsed or refractory diffuse large B-cell lymphoma.
Polatuzumab vedotin is a first-in-class anti-CD79b antibody-drug conjugate.
Results of the randomized phase 1b/phase 2 GO29365 study showed the addition of the agent to bendamustine and rituximab extended median OS (12.4 months vs. 4.7 months, HR = 0.42; 95% CI, 0.24-0.75; exploratory endpoint) among patients with relapsed or refractory DLBCL who were not eligible for hematopoietic stem cell transplant.
Independent review committee analysis showed a higher complete response rate (40% vs. 18%) among patients assigned the polatuzumab vedotin regimen.
The FDA is expected to make a decision on the application by Aug. 19.
• Entrectinib (Genentech) for treatment of adults and pediatric patients with neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive, locally advanced or metastatic solid tumors who progressed after prior therapies or as initial therapy when no acceptable standard therapies exist.
The priority review designation also applies to its use for treatment of patients with metastatic ROS1-positive non-small cell lung cancer.
The FDA is expected to make a decision on the application by Aug. 18.
“Entrectinib represents a unique approach to cancer treatment that can potentially target a range of hard-to-treat and rare NTRK fusion-positive tumors regardless of their site of origin, as well as treat ROS1-positive non-small cell lung cancer,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a company-issued press release. “By combining comprehensive genomic profiling with actionable targeted therapies like entrectinib, we are advancing our personalized health care goal to find the right treatment for each patient.”
The FDA previously granted breakthrough therapy designation to entrectinib for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors in adults or pediatric patients who progressed after prior therapies or have no acceptable standard therapies.