FDA News

FDA approves Opdivo for metastatic small cell lung cancer

The FDA approved nivolumab for the treatment of patients with metastatic small cell lung cancer who progressed after platinum-based chemotherapy and at least one other line of therapy.

The approval marks the first immuno-oncology treatment for this population and the first new medication in almost 20 years, according to the manufacturer.

“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,” Sabine Maier, MD, development lead of thoracic cancers at Bristol-Myers Squibb, said in a company-issued press release. “This approval builds on our heritage of bringing immuno-oncology therapies to patients with other types of thoracic cancers.”

The FDA based this accelerated approval of nivolumab (Opdivo, Bristol-Myers Squibb) — a PD-1 immune checkpoint inhibitor — on results from the phase 1/2 CheckMate-032 study. The multicenter, open-label, ongoing study included 245 patients with small cell lung cancer who experienced disease progression after platinum-based chemotherapy. Researchers submitted efficacy data from 109 patients who received nivolumab after disease progression on platinum-based chemotherapy and at least one other prior line of therapy to support this indication.

Results from a blinded independent central review showed 12% (95% CI, 6.5-19.5) responded to treatment regardless of PD-L1 expression.

Twelve patients (11%) had a partial response and one patient (0.9%) had a complete response.

Among the responders, the median duration of response was 17.9 months (95% CI, 7.9-42.1).

“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,” Andrea Ferris, president and chairman of LUNGevity Foundation, said in the press release. “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.”

Serious adverse reactions occurred among 45% of patients. Ten percent of patients discontinued nivolumab. In 25% of patients, investigators withheld one dose of nivolumab due to an adverse reaction.

The most common adverse reactions included fatigue (45%), decreased appetite (27%), musculoskeletal pain (25%), dyspnea (22%), nausea (22%), diarrhea (21%), constipation (20%) and cough (20%). The most frequent serious adverse reactions reported in at least 2% of patients included pneumonia, dyspnea, pneumonitis, pleural effusion and dehydration.

The FDA approved a dose of 240 mg every 2 weeks by IV infusion until disease progression or unacceptable toxicity.

Nivolumab also is indicated for the treatment of certain patients with metastatic non-small cell lung cancer and certain patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

The FDA approved nivolumab for the treatment of patients with metastatic small cell lung cancer who progressed after platinum-based chemotherapy and at least one other line of therapy.

The approval marks the first immuno-oncology treatment for this population and the first new medication in almost 20 years, according to the manufacturer.

“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,” Sabine Maier, MD, development lead of thoracic cancers at Bristol-Myers Squibb, said in a company-issued press release. “This approval builds on our heritage of bringing immuno-oncology therapies to patients with other types of thoracic cancers.”

The FDA based this accelerated approval of nivolumab (Opdivo, Bristol-Myers Squibb) — a PD-1 immune checkpoint inhibitor — on results from the phase 1/2 CheckMate-032 study. The multicenter, open-label, ongoing study included 245 patients with small cell lung cancer who experienced disease progression after platinum-based chemotherapy. Researchers submitted efficacy data from 109 patients who received nivolumab after disease progression on platinum-based chemotherapy and at least one other prior line of therapy to support this indication.

Results from a blinded independent central review showed 12% (95% CI, 6.5-19.5) responded to treatment regardless of PD-L1 expression.

Twelve patients (11%) had a partial response and one patient (0.9%) had a complete response.

Among the responders, the median duration of response was 17.9 months (95% CI, 7.9-42.1).

“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,” Andrea Ferris, president and chairman of LUNGevity Foundation, said in the press release. “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.”

Serious adverse reactions occurred among 45% of patients. Ten percent of patients discontinued nivolumab. In 25% of patients, investigators withheld one dose of nivolumab due to an adverse reaction.

The most common adverse reactions included fatigue (45%), decreased appetite (27%), musculoskeletal pain (25%), dyspnea (22%), nausea (22%), diarrhea (21%), constipation (20%) and cough (20%). The most frequent serious adverse reactions reported in at least 2% of patients included pneumonia, dyspnea, pneumonitis, pleural effusion and dehydration.

The FDA approved a dose of 240 mg every 2 weeks by IV infusion until disease progression or unacceptable toxicity.

Nivolumab also is indicated for the treatment of certain patients with metastatic non-small cell lung cancer and certain patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

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