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FDA green lights BMS’ Opdivo for ‘hard-to-treat’ small cell lung cancer

Becomes the first checkpoint inhibitor for this indication


Bristol-Myers Squibb’s (BMS) immuno-oncology blockbuster Opdivo has been cleared by the US Food and Drug Administration (FDA) to treat small cell lung cancer (SCLC) patients.

The treatment, which was approved on Friday, has claimed the title of the first and only immuno-oncology treatment for SCLC patients who have received platinum chemo and at least one other form of therapy.

Prior to this approval, the only treatments available for this group of patients were chemotherapy, radiotherapy and surgery.

However, treating the disease from a ‘different angle’, Opdivo can target and block the activity of PD-1, a protein that prevents T cells from recognising and attacking inflamed tissues and cancer cells.

Commenting on the win, Sabine Maier, development lead, thoracic cancers, BMS, said: “We recognise the critical need to provide patients with cancer therapies that may offer more durable responses – particularly for those living with aggressive diseases like small cell lung cancer.

This ‘hard-to-treat’ disease accounts for up to 15% of all lung cancers, and 27,000 cases of SCLC are expected in the US this year.

Maier added: “This approval builds on our heritage of bringing immuno-oncology therapies to patients with other types of thoracic cancers. It also reinforces our commitment to bring transformative treatments to patients in urgent need of effective new options.”

The approval was based on data from the phase I/II trial programme CheckMate 032, which showed a median response lasting 17.9 months in the 12% of patients who responded to treatment.

It’s a significant win for BMS, which is chasing rival Merck & Co’s anti-PD-1 therapy Keytruda in the lung cancer space, although Opdivo now has a leg up in the small cell lung cancer indication thanks to this recent approval.

Keytruda is still leading the pack though, following its two FDA approvals in previously untreated non-small cell lung cancer (NSCLC).

Article by
Gemma Jones

20th August 2018

From: Regulatory



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