A Drug Indication Is Pulled From the Market: Now What?


An immunotherapy agent recently had its FDA approval pulled from the American market. But this may not be as bad as it sounds, experts say.

Drug approvals are seemingly happening faster than ever before, with many therapies being granted accelerated approvals based on promising interim results from clinical trials. However, when the data in later confirmatory trials is not as good, treatments may be pulled from the market.

This was recently the case with nivolumab (Opdivo), which was pulled for the treatment of patients with small cell lung cancer (SCLC) whose disease progressed after chemotherapy and 1 or more other treatment.

Back in 2018, the immunotherapy agent was the first checkpoint inhibitor to be approved for this patient population, based on findings from the phase 1/2 CheckMate-032 trial. However, confirmatory trials showed that the drug did not meet the primary endpoint of overall survival, leading to the FDA and drug manufacturer (Bristol Myers Squibb) to withdraw its approval.

Despite the indication being revoked, nurses and other health care providers do not need to rush to change treatment plans for patients with SCLC on the drug if it is working. Since it is a third-line drug for the rarer form of lung cancer, the number of patients with SCLC receiving nivolumab is likely to be small.

“I would explain to patients that while we are not starting patients on the drug going forward, if they are currently on it, and it is working to control their cancer and they are tolerating it without significant toxicity, then it is likely we would keep them on it,” said Beth Sandy, CRNP, a thoracic oncology nurse practitioner at Penn Medicine’s Abramson Cancer Center.

As far as insurance coverage goes, the regimen likely will not lose coverage for patients who are on it and doing well. “If there are patients who are still receiving nivolumab for SCLC and still responding, it is very unlikely that insurances will stop coverage on a drug that is currently controlling their cancer,” Sandy said.

Additionally, insurance companies have covered regimens that were not FDA approved, but were a part of the National Comprehensive Cancer Network (NCCN) guidelines, explained Timothy Burns, MD, medical oncologist at UPMC Hillman Cancer Center.

“I encourage these patients to go on clinical trials, but no insurance company goes and says, ‘Well you don’t have a label for this,” Burns said. “So, in the short-term, patients can stay on Opdivo, or you can have a discussion about switching them to [pembrolizumab],” Burns said.

Pembrolizumab (Keytruda), also a checkpoint inhibitor, was approved by the FDA in 2019 for the treatment of patients with metastatic SCLC whose disease progressed on or after platinum-based chemotherapy and 1 or more prior line of therapy.

Whether a patient stays on Opdivo or not, nurses can be confident that there are now more treatment options than ever for SCLC.

“For decades, we did not have any new treatments that offered significant improvements in survival,” Sandy said.

“But in the past 2 years, we have seen the addition of 2 different immunotherapy drugs in the frontline setting combined with chemotherapy that have a statistically significant improvement in overall survival. We have also seen the addition of a novel chemotherapeutic agent, lurbinectedin, become approved in the second-line setting, offering an additional chance of response of chemotherapy for this aggressive disease.”

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