Author | Nichole Tucker

Articles

FDA Approval Being Considered for Neoadjuvant/Adjuvant Pembrolizumab +/- Chemo in Early TNBC

July 30, 2020

Article

The FDA has accepted a supplemental Biologics License Application submitted for neoadjuvant pembrolizumab combined with chemotherapy and adjuvant pembrolizumab monotherapy for the treatment of patients with high-risk early-stage triple-negative breast cancer.

Pembrolizumab Plus Chemotherapy on the Road to FDA Approval for mTNBC, Granted Priority Review

July 30, 2020

Article

The FDA accepted a supplemental Biologics License Application for and granted Priority Review to pembrolizumab in combination with chemotherapy, which is intended for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1.

FDA Grants Breakthrough Therapy Designation to Osimertinib in EGFR+ Lung Cancer

July 30, 2020

Article

The FDA granted Breakthrough Therapy designation to osimertinib as adjuvant treatment of patients with stage IB-IIIA EGFR-mutated non–small cell lung cancer following complete tumor resection with curative intent.

Pembrolizumab Plus Nab-Paclitaxel May Be an Option for Switch Maintenance Following Chemo in mUC

July 29, 2020

Article

The combination of pembrolizumab plus nab-paclitaxel demonstrated clinically meaningful and sustainable responses, along with prolonged progression-free survival when administered as salvage therapy to patients with metastatic urothelial carcinoma.