FDA Grants Priority Review to Rucaparib for BRCA1/2-Positice mCRPC
January 16, 2020
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
FDA Grants Priority Review to Frontline Nivolumab-Ipilimumab Combo for NSCLC
January 15, 2020
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.
FDA Approves Avapritinib for Resectable or Metastatic Gastrointestinal Stromal Tumor
January 10, 2020
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.
FDA Approves Pembrolizumab for Treatment of Certain Patients with NMIBC
January 8, 2020
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.
FDA Approves First PARP Inhibitor as Frontline Maintenance in Pancreatic Cancer
December 30, 2019
The FDA approved olaparib for the maintenance treatment of adult patients with germline BRCA-mutated metastatic pancreatic adenocarcinoma.
FDA Approves Trastuzumab Deruxtecan for HER2-Positive Breast Cancer
December 20, 2019
The FDA granted accelerated approval to trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
FDA Approves Enfortumab Vedotin for Metastatic or Advanced Urothelial Cancer
December 19, 2019
The FDA granted accelerated approval to enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
FDA Approves Enzalutamide for mCSPC Treatment
December 17, 2019
The FDA approved enzalutamide for the treatment of patients with metastatic castration-sensitive prostate cancer.
Long-Term Follow-Up Supports Anastrozole Treatment to Prevent Breast Cancer Recurrence
December 12, 2019
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.
Addition of S-1 to Endocrine Therapy Postoperatively Improves Survival in HR+, HER2- Breast Cancer
December 11, 2019
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.
