- A European Medicines Agency risk committee last week recommended Gilead's cancer drug Zydelig could remain on the market, four months after an increased rate of patient side effects had raised safety concerns and prompted Gilead to halt six clinical trials.
- The Pharmacovigilance Risk Assessment Committee (PRAC) said Zydelig's benefits outweighed its risks in treating two types of blood cancer, although it did recommend all patients taking Zydelig also be given antibiotics to prevent pneumonia.
- A higher rate of infections, including pneumonia, had been observed in three clinical trials investigating Zydelig's use in combination with other cancer medicines. A number of patients taking part in the trials had died.
The recommendations released by PRAC last week did not change much from the agency's first guidance after the higher rate of side effects was reported.
According to the guidelines, patients should be treated with antibiotics while receiving Zydelig to help lower risk of a lung infection known as Pneumocystis jirovecii pneumonia. Antibiotic treatment should continue for at least two to six months after treatment ends and patients' white blood cell counts should be monitored.
During the early part of the investigation, the EMA cautioned physicians not to start Zydelig in patients with two mutated forms of chronic lymphocytic leukemia (17p deletion or TP53 mutation). But the PRAC has now concluded those patients can be safely treated as long as they take no other alternative treatment at the same time.
The recommendations are now being sent to the Committee for Medicinal Products for Human Use for finalization.
Zydelig is Gilead's first foray into oncology and sales have been relatively small so far, totaling $132 million last year.