BMS gets go-ahead for PD-1 inhibitor Opdivo in US

Bristol-Myers Squibb (BMS) has won approval in the US for its cancer immunotherapy Opdivo, which will compete head-to-head in the anti-PD-1 market with Merck & Co’s Keytruda.

The FDA granted accelerated approval to Opdivo (nivolumab) for the second-line treatment of patients with unresectable or metastatic melanoma, just over three months after Keytruda was approved for the same indication in the US.

Opdivo is indicated for use in patients whose disease has progressed after treatment with BMS’ CTLA-4 inhibitor Yervoy (ipilimumab) and – if the tumour is BRAF V600 mutation-positive – a BRAF inhibitor such as Roche’s Zelboraf (vemurafenib) or GlaxoSmithKline’s Tafinlar (dabrafenib).

BMS says it plans to launch the drug in the US within the next couple of weeks and will price it at $12,500 per month, which is on a par with Keytruda.

Approval was based on the open-label CheckMate-037 trial, which enrolled 405 patients and showed that 32 per cent of participants receiving Opdivo had their tumours shrink. This effect lasted for more than six months in approximately one-third of the responding participants.

Opdivo may not have been the first PD-1-targeting drug to reach the market in the US, but it was the first to market, having been approved in Japan in July.

Approval in melanoma could be followed by additional indications including non-small cell lung cancer (NSCLC) and renal cell carcinoma – both already filed – as well as other solid tumours such as bladder cancer, along with haematological cancers including Hodgkin’s lymphoma.

Analysts at Goldman Sachs have predicted that peak sales of nivolumab will reach $7 billion by 2025, with the entire PD-1 inhibitor class representing a $10 billion-$15 billion market opportunity at peak, although others have predicted the class could eventually bring in $25 billion-$30 billion.

In addition to Keytruda, Opdivo is also facing competition in future from other PD-1 candidates, including Roche’s MPDL3280A, AstraZeneca’s MEDI4736 and other experimental drugs from Pfizer/Merck KGaA and Novartis, among others.

“The emergence of effective immuno-oncology therapies that are capable of successfully treating metastatic melanoma has reinvigorated the field of cancer immunology with an optimism that immune-based treatments will play a central role in therapeutic strategies for cancer patients,” commented Jill O’Donnell-Tormey, chief executive of the Cancer Research Institute (CRI), a non-profit organisation dedicated to advancing the science of cancer immunology.

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Merck wins race to market PD-1 inhibitor in US

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