The FDA granted priority review to rucaparib for the treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castration-resistant prostate cancer.
Kristie L. Kahl
The FDA accepted and granted priority review to the supplemental biologics license application for nivolumab in combination with ipilimumab for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer.
The FDA approved avapritinib for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.
The FDA approved pembrolizumab for the treatment of patients with BCG–unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or chose to not undergo cystectomy.
The FDA approved olaparib for the maintenance treatment of adult patients with germline BRCA-mutated metastatic pancreatic adenocarcinoma.
The FDA granted accelerated approval to trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
The FDA granted accelerated approval to enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
The FDA approved enzalutamide for the treatment of patients with metastatic castration-sensitive prostate cancer.
Five years of treatment with anastrozole safely and effectively prevented breast cancer recurrence in high-risk postmenopausal women at 10.9 years of follow-up.
Adjuvant therapy with S-1, an oral fluoropyrimidine-based drug, plus endocrine therapy postoperatively significantly increased invasive disease-free survival (IDFS) in patients with HR-positive, HER2-negative breast cancer.