FDA approves Bristol Myers Squibb’s Opdivo in small-cell lung cancer
pharmafile | August 20, 2018 | News story | Sales and Marketing | Bristol-Myers Squibb, FDA, approval, bristol myers squibb, lung cancer, opdivo
The FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) for patients with metastatic small-cell lung cancer (SCLC), as the first and only Immuno-Oncology treatment option for whose disease has progressed after platinum-based chemotherapy and at least one other line of therapy.
The approval was granted on an accelerated approval basis however continued approval may be based on verification and description of clinical benefit in confirmatory trials.
“At Bristol-Myers Squibb, we recognize 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,” said Dr Sabine Maier, Development Lead, thoracic cancers, Bristol-Myers Squibb. “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 bringing transformative treatments to patients in urgent need of effective new options.”
Of 109 patients who received the drug 12% responded to treatment. However among those who responded to the drug the median Duration of Response (DoR) was 17.9 months. Serious adverse reactions occurred in 45% of patients while the drug was discontinued in 10% of patients.
Small cell lung cancer accounts for around 10-15% of all lung cancers. From the time of diagnosis, five year survival rates for extensive stage SCLC are around 2%.
“Small cell lung cancer can be a very challenging disease, particularly for those who have already been through multiple types of treatment, as most patients relapse within a year of diagnosis,” said Andrea Ferris, president and chairman of LUNGevity Foundation. “This approval marks a major milestone for the patients touched by this unrelenting disease and may motivate them to pursue further treatment where there previously were no other approved options.
Louis Goss
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