ARTICLE | Regulation

FDA’s approval of Akeega niraparib and abiraterone acetate from Janssen to treat BRCA-positive metastatic castration-resistant prostate cancer (mCRPC) comes two months after Lynparza olaparib plus abiraterone from AstraZeneca plc (LSE:AZN; NASDAQ:AZN) was approved in the same indication and is another sign of PARP inhibitors’ growing importance in the evolving landscape for the disease. Janssen obtained the rights to niraparib in prostate cancer from Tesaro Inc., which was acquired by GSK plc (LSE:GSK; NYSE:GSK) in 2019; the British pharma markets niraparib to treat ovarian, fallopian tube and primary peritoneal cancers as Zejula. Akeega was approved in Europe in April.

Atreca Inc. (NASDAQ:BCEL) said it will suspend development of its lone clinical program, ATRC-101, and restructure as it shifts focus to a pipeline of preclinical antibody-drug conjugates. ATRC-101, an IgG antibody with a driver antigen engagement targeting novel RNP complex, was in Phase Ib testing for solid tumors. The biotech will cut 40% of its staff as it prepares to nominate a clinical candidate this year from its APN-497444 program, which targets a tumor-specific glycan and will be developed as an ADC. Atreca, which went public in 2021 at $17 per share, lost 37% to $0.56 on Friday, giving it market cap of about $20 million…

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• Source: https://www.biocentury.com/article/648904/aug-11-quick-takes-janssen-gains-prostate-cancer-approval