BMS to make Opdivo submission
pharmafile | July 11, 2014 | News story | Sales and Marketing | BMS, Cancer, EMA, FDA, ono, opdivo, pd-1
Bristol-Myers Squibb is to submit cancer treatment Opdivo to the US authorities after the drug received its first approval in Japan this week.
Ono Pharmaceutical – the Japanese company with whom BMS has a licensing agreement – was given a licence for Opdivo (nivolumab), an anti-PD-1 (programmed death-1) monoclonal antibody, for use in adults with advanced melanoma.
The intravenous infusion is thought to work by blocking the interaction of PD-1 with its ligands PD-L1 and PD-L2, giving the body’s immune system more chance of recognising cancerous cells and killing them.
BMS says it will aim to make a similar submission for the drug in this deadliest form of skin cancer to the Food and Drug Administration in the third quarter of the year.
This would be based on the Phase III Checkmate -037 programme, which compared Opdivo to dacarbazine or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with BMS’s own Yervoy (ipilimumab).
In 2013, the FDA granted Opdivo ‘fast track’ designation in non-small cell lung cancer (NSCLC), melanoma and renal cell carcinoma (RCC), while in April BMS began a rolling submission of the drug in third-line pre-treated squamous cell NSCLC which it expects to complete by the end of 2014.
The FDA also gave the drug ‘breakthrough therapy’ status in May for patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab.
“We continue to collaborate closely with the FDA on Opdivo and the planned submission in advanced melanoma represents an important step forward in our company’s commitment to deliver innovative treatment options for patients with cancer,” says Michael Giordano, BMS’s head of oncology development.
BMS is looking at Opdivo as monotherapy or in combination with other treatments in various tumour types across 35 trials in NSCLC, melanoma, RCC, head and neck cancer, glioblastoma and non-Hodgkin lymphoma.
The manufacturer has rights to develop and commercialise Opdivo outside of Japan, Korea and Taiwan because it bought Medarex, which came up with the drug in a research collaboration with Ono.
Meanwhile, Merck’s pembrolizumab last week took a big step towards becoming Europe’s first PD-1 cancer treatment as the European Medicines Agency accepted the medicine for review.
The EMA is looking at pembrolizumab (MK-3475) for the treatment of advanced melanoma after it was found to have a one-year overall survival rate of 69 per cent.
Merck says more regulatory filings outside Europe are planned by the end of the year and analysts are expecting peak sales of around $500 million for a licence in melanoma.
Adam Hill
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