June 2019 is a busy month for approval applications for the U.S. Food and Drug Administration as the regulatory agency has a slate of PDUFA dates.
U.S. drugmaker Merck & Co. Inc. agreed to buy Peloton Therapeutics Inc. for $1.05 billion in cash, gaining access to the privately held company’s lead kidney cancer drug candidate.
EMD Serono and Pfizer announced that the U.S. FDA approved Bavencio (avelumab) in combination with Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma.
The Food and Drug Administration approved Merck & Co.’s cancer therapy Keytruda as part of a combination therapy for previously untreated patients with the most common type of kidney cancer.
Keytruda In Combination With Inlyta Reduced Risk Of Death By Nearly Half Compared To Sunitinib As First-Line Treatment For Advanced RCC
Merck & Co. announced presentation of the full results from the pivotal Phase 3 KEYNOTE-426 trial investigating the company’s anti-PD-1 therapy Keytruda in combination with Inlyta, a tyrosine kinase inhibitor, for the first-line treatment of advanced renal cell carcinoma (RCC) at the 2019 Genitourinary Cancers Symposium.
Opdivo Plus Low-Dose Yervoy Demonstrates Continued Survival Benefit at 30-Month Follow-up in Patients with Previously Untreated Advanced or Metastatic RCC
Bristol-Myers Squibb Company announced new results from the Phase 3 CheckMate -214 study, showing that therapy with Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) continued to demonstrate long-term survival benefits in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC).
Aveo Oncology’s Phase III study of tivozanib for highly refractory advanced or metastatic renal cell carcinoma (RCC) met the primary endpoint of demonstrating a statistically significant benefit in PFS.
An Opdivo-Yervoy combo yielded a significantly longer treatment-free survival period for patients with previously untreated advanced or metastatic renal cell carcinoma than standard of care sunitinib.
Merck KGaA said the immunotherapy Bavencio, jointly developed with Pfizer Inc., delayed the progression of kidney cancer when used in combination with Pfizer’s Inlyta drug in a late-stage study.
Eisai’s Phase III Trial Results of Anticancer Agent Lenvatinib in Hepatocellular Carcinoma Published in The Lancet
Eisai Co. Ltd. announced that the results of a Phase III study of its in-house discovered and developed anticancer agent lenvatinib mesylate in patients with hepatocellular carcinoma were published in the online version of The Lancet.