Bristol-Myers Squibb has received approval from the US Food and Drug Administration (FDA) for its Opdivo (nivolumab) medicine to treat metastatic small cell lung cancer (SCLC).
Opdivo is said to be the first and only immuno-oncology therapy for SCLC patients whose condition progressed following platinum-based chemotherapy and at least one other line of therapy.
The FDA has granted its authorisation under accelerated approval. Continued approval for this indication is pending and contingent upon validation and description of clinical benefit in confirmatory clinical trials.
Bristol-Myers Squibb thoracic cancers development lead Sabine Maier said: “At Bristol-Myers Squibb, we recognise the critical need to provide patients with cancer therapies that may offer more durable responses – particularly for those living with hard-to-treat, aggressive diseases like small cell lung cancer.
“This approval builds on our heritage of bringing immuno-oncology therapies to patients with other types of thoracic cancers.”
The approval is based on overall response rate (ORR) and duration of response (DOR) data. It comes after the FDA reviewed results from the SCLC cohort of the ongoing Phase I/II CheckMate-032 trial.
This trial is designed to assess 3mg/kg intravenous dose of Opdivo in 245 small cell lung cancer patients who experienced disease progression after platinum-based chemotherapy.
Of the 109 subjects administered with Opdivo, 12% achieved treatment response, 11% participants experienced a partial response and 0.9% had a complete response.
Among all responders, the median DOR was 17.9 months.
Around 10% of patients had to discontinue the drug, while one dose had to be withheld in 25% due to an adverse reaction. It was found that 45% of subjects experienced serious adverse reactions.
Previously, Opdivo secured approval for treating metastatic non-small cell lung cancer (NSCLC) and recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
Both the indications are for patients whose cancer progressed on or after platinum-based therapy.