FDA accepts supplemental Biologics License Application for Opdivo in patients with previously untreated advanced melanoma
Posted: 30 April 2015 |
The FDA has accepted for filing and review the sBLA for Opdivo for the treatment of previously untreated patients with unresectable or metastatic melanoma…
The U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental Biologics License Application (sBLA) for Bristol-Myers Squibb Company’s Opdivo (nivolumab) for the treatment of previously untreated patients with unresectable or metastatic melanoma.
The FDA also granted Priority Review for this application. The projected FDA action date is 27 August 2015.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that has received approval from the FDA as a monotherapy in two cancer indications.
Application includes CheckMate -066, a clinical trial of Opdivo vs. dacarbazine chemotherapy in patients who had not received prior therapy
Opdivo was first approved by the FDA in December 2014 for patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. This initial indication was approved under accelerated approval based on tumour response rate and durability of response from CheckMate -037 clinical trial results. This new sBLA accepted by the FDA includes data from CheckMate -066, which evaluated Opdivo in treatment naïve patients with BRAF wild-type advanced melanoma as compared to dacarbazine chemotherapy (DTIC). In the trial, safety and tolerability were well-characterised with fewer treatment-related Grade 3/4 adverse events observed with Opdivo than dacarbazine.
“The CheckMate -066 trial marked the first time that a PD-1 immune checkpoint inhibitor showed a survival benefit in a randomised Phase III trial,” said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “We look forward to continuing to work with the FDA to ensure cancer patients are provided the latest clinical advances that have the potential for improved responses and long-term survival.”
For more information about Bristol-Myers Squibb Company, please visit www.bms.com.
