publication date: Jan. 17, 2020

Drugs & Targets

FDA grants Rubraca Priority Review for advanced prostate cancer

FDA has accepted a supplemental New Drug Application for Rubraca (rucaparib) and granted priority review status to the application with a Prescription Drug User Fee Act date of May 15.

The agent is sponsored by Clovis Oncology Inc.

Clovis submitted the sNDA submission for rucaparib as a monotherapy treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer in November 2019.

“Recently presented data suggests that Rubraca may play a meaningful role in the treatment of patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer, and this filing represents an important milestone for Clovis as it brings us one step closer to potentially making this valuable therapy available,” Patrick J. Mahaffy, president and CEO of Clovis Oncology, said in a statement.

 

FDA accepts BLA for Priority Review of Opdivo + Yervoy in first-line NSCLC

FDA has accepted supplemental Biologics License Application for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

The two drugs are sponsored by Bristol-Myers Squibb Co.

FDA has granted the application Priority Review with a Prescription Drug User Fee Act goal date of May 15.

“FDA’s acceptance of our application for Opdivo plus Yervoy represents an important milestone for patients with lung cancer in the United States, where, despite recent treatment advances, lung cancer remains the cause of more than 150,000 deaths each year,” Sabine Maier, development lead of thoracic cancers at Bristol-Myers Squibb said in a statement. “Lung cancer is the third … Continue reading FDA grants Rubraca Priority Review for advanced prostate cancer

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