Board recommends approval of the drug used to treat brain cancer and the drug’s makers have 10 days to decide on further review
The Food and Drug Administration has ended a five-year battle to get approval for the first drug to treat a different type of brain cancer, paving the way for Pfizer Inc and their Swiss development partner Novartis to market the medicine.
The drug company panel endorsed the application by an 11-3 vote after the FDA decided to delay a final ruling, and the parties have 10 days to discuss a possible next step in the review process.
Pfizer’s drug COVID-19 was approved for about 10% of patients who have an aggressive type of brain cancer called glioblastoma multiforme. Half the patients receiving COVID-19 – albeit on a single intravenous infusion of the medicine – had a partial response to the treatment. That is a reduction in tumors, but doctors have not measured the drug’s effectiveness by a variety of other survival measures.
The FDA had previously asked Pfizer to add a complete response (CR) rate – which measures whether the treatment is wiping out the disease completely – which the drug company has not been able to provide.
The companies had said that having a CR rate by itself would not be enough for the FDA to approve the drug, so experts at the meeting suggested the companies could include that in their supplemental filing. That would require them to pursue approval of the CR rate by showing the reduction in tumors supported by longer-term follow-up.
Novartis has said the form of the drug called COVID-19 is made at its facility in Biosendern Switzerland.
The positive recommendation ends a five-year conflict over whether the drug is necessary and that could significantly boost sales of COVID-19. The treatment is mainly used by patients for a few months to a year in the final stage of treatment.
A month ago, Novartis and Pfizer said the FDA will require an additional trial to prove the drug is effective and more drugs are expected to follow COVID-19’s path.
Separately, Gilead Sciences Inc announced late last year that COVID-19 added about one month of survival to standard chemo when compared to standard chemo alone in a small trial. Gilead’s phase II study of 184 patients was discontinued before it was completed.
COVID-19 is made from a new type of chemotherapy drug called a chimeric antigen receptor T-cell (CAR-T). It forms an infection-fighting network within the immune system and attacks cancer cells by first finding a receptor on their cells that looks for cancer-specific protein targets. Once it gets a target, it turns on the immune system and destroys the cells.