FDA Grants Priority Review to Keytruda Plus Chemotherapy for Lung Cancer Subtype

Excerpt:

“The FDA granted priority review designation to a supplemental biologics license application that seeks approval of pembrolizumab for use in combination with chemotherapy as first-line treatment of metastatic squamous non-small cell lung cancer regardless of PD-L1 expression.

“The agency set a target action date of Oct. 30.”

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Talazoparib Granted Priority Review by FDA for BRCA+ Metastatic Breast Cancer

Excerpt:

“A new drug application (NDA) for the PARP inhibitor talazoparib has been granted a priority review by the FDA for the treatment of patients with germline BRCA mutation–positive, HER2-negative locally advanced or metastatic breast cancer, according to Pfizer, the manufacturer of the agent.

“In results from the phase III EMBRACA trial, on which the application is based, talazoparib reduced risk of disease progression or death by 46% compared with chemotherapy in patients with BRCA-positive advanced breast cancer. At a median follow-up of 11.2 months, the Median progression-free survival (PFS) at the median follow-up of 11.2 months was 8.6 months (95% CI, 7.2-9.3) with talazoparib versus 5.6 months (95% CI, 4.2-6.7) with physician’s choice of therapy (HR, 0.54; 95% CI, 0.41-0.71; P <.0001). The objective response rate (ORR) was 62.6% (95% CI, 55.8-69.0) compared with 27.2% (95% CI, 19.3-36.3), respectively (odds ratio, 4.99; 95% CI, 2.9-8.8; 2-sided P value <.0001).”

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FDA Grants Priority Review to Tecentriq Combo for First-Line Treatment of Advanced Lung Cancer

Excerpt:

“The U.S. Food and Drug Administration has granted priority review to Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and chemotherapy medications Taxol (paclitaxel) and carboplatin for first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC).

“Priority review of Roche’s supplemental Biologics License Application means the FDA will decide whether or not to approve the therapy within six months instead of the standard 10 months. A decision is now expected by Sept. 5. To be granted priority review, a therapy candidate must show potential to provide significant benefits for the treatment, prevention, or diagnosis of a disease.”

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FDA Grants Priority Review to Tecentriq Combo for First-Line Treatment of Advanced Lung Cancer

Excerpt:

“The U.S. Food and Drug Administration has granted priority review to Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and chemotherapy medications Taxol (paclitaxel) and carboplatin for first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC).

“Priority review of Roche’s supplemental Biologics License Application means the FDA will decide whether or not to approve the therapy within six months instead of the standard 10 months. A decision is now expected by Sept. 5. To be granted priority review, a therapy candidate must show potential to provide significant benefits for the treatment, prevention, or diagnosis of a disease.”

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FDA Accepts sBLA, Grants Priority Review to Atezolizumab for Initial Treatment of Metastatic Nonsquamous NSCLC

Excerpt:

“The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in combination with bevacizumab (Avastin), paclitaxel, and carboplatin for the first-line treatment of metastatic nonsquamous non–small cell lung cancer (NSCLC). The FDA is expected to make a decision on approval by September 5, 2018.

” ‘Our phase III results showed atezolizumab in combination with bevacizumab, paclitaxel, and carboplatin has the potential to provide a significant survival benefit in the initial treatment of metastatic nonsquamous non–small cell lung cancer,’ said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Genentech.”

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FDA Grants Priority Review to Keytruda as Part of Non-Small Cell Lung Cancer Regimen

Excerpt:

“The FDA granted priority review to a supplemental biologics license application that seeks approval of pembrolizumab for use in combination with pemetrexed and platinum chemotherapy for the treatment of patients with newly diagnosed metastatic nonsquamous non-small cell lung cancer.

“Pembrolizumab (Keytruda, Merck) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.”

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FDA Grants Opdivo Priority Review for Small Cell Lung Cancer

Excerpt:

“The FDA has granted a priority review to a supplemental biologics license application (sBLA) for Opdivo (nivolumab) for the treatment of patients with small cell lung cancer (SCLC) with disease progression following two or more lines of therapy, according to Bristol-Myers Squibb, the manufacturer of the PD-1 inhibitor.

“The sBLA is based on data from the phase 1/2 CheckMate-032 trial, in which single-agent Opdivo led to a median overall survival (OS) of 4.4 months and a one-year OS rate of 33 percent in patients with progressive SCLC following one or more prior lines of therapy. Under the priority review, the FDA is scheduled to make its decision by Aug. 16, 2018.”

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Xtandi Granted Priority Review for Prostate Cancer Treatment

Excerpt:

“The Food and Drug Administration granted Xtandi (enzalutamide) a priority review to a supplemental new drug application for the treatment of patients with nonmetastatic castration-resistant prostate cancer, according to the companies developing the drug, Pfizer and Astellas.

“The sNDA is based on data from the phase 3 PROSPER trial in which the combination of Xtandi and androgen deprivation therapy (ADT) reduced the risk of metastases or death by 71 percent compared with ADT alone for patients with nonmetastatic CRPC. In the double-blind study, the median metastasis-free survival (MFS) was 36.6 months with Xtandi plus ADT versus 14.7 months with ADT alone.”

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FDA Grants Priority Review to Lorlatinib in ALK-Positive NSCLC

Excerpt:

“On February 12, the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to Pfizer’s new drug application for lorlatinib. The Prescription Drug User Fee Act goal date for a decision by the FDA is in August 2018.

“Lorlatinib is an investigational, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor for the treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) previously treated with one or more ALK tyrosine kinase inhibitors. It has been shown to be highly active in preclinical lung cancer models harboring chromosomal rearrangements of both ALK and ROS1. Lorlatinib was specifically designed to inhibit tumor mutations that drive resistance to other ALK inhibitors and to penetrate the blood-brain barrier.”

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