Gilead’s Zydelig Medical Benefits Outweighs Clinical Trial Deaths: EMA
European Medical Agency (EMA)’s PRAC (Pharmacovigilance Risk Assessment Committee) concluded its review on the Gilead’s blood cancer drug, Zydelig and confirmed that the drug will remain in the market with some updated recommendations because its medical benefits outweigh its risks.
EMA started the review on March 2016 after severe side effects including death in 3 clinical trials conducted by Gilead in monotherapy as well as in combination therapy with other drugs. Mostly the adverse events were severe infections, due to unapproved medicine combinations, unauthorized quantity of the drug used and treating the patients with different symptoms that is not in the prescribed drug label. This led the committee to set up a prompt review.
According to the committee the reason for their green signal to the drug was its benefits and advantages that outweigh the risk of its use. Zydelig is one of the few cancer drugs which are used for the treatment of the most rare and incurable form of B-cell cancer chronic lymphocytic leukaemia (CLL) and follicular lymphoma (A type of non-Hodgkin lymphoma).
ZYDELIG® (idelalisib) is a protein oral inhibitor of phosphoinositide 3-kinase (PI3K) delta. PI3K is known to play important role in the activation, proliferation and viability of B cells.
Though the drug passed the approval but EMA had set up few stipulations on the use of the drug. Firstly, the PRAC committee accepted the fact that the drug cause severe infections including Pneumocystis jirovecii pneumonia and can only be given with regular use of antibiotics during the treatment up to minimum 2 or maximum 6 months after the treatment.
Secondly, the patient suffering from general infection cannot be treated with the drug. Those patients who are being treated needs to be regularly monitored for infection by blood test to check the white cell counts, decrease of which results in infection.
Most important of all, PRAC notified the physician to stop prescribing the drug on newly detected and untreated CLL patients because of genetic mutation (17p deletion or TP53 mutation). Also, the drug cannot be used with other alternative treatments and in combination therapy.
The above mentioned recommendations of PRAC committee will be further passed on to Committee for Medicinal Products for Human Use (CHMP) for final decision on the stipulations.
The last two conditions had brought a setback to Gilead’s dream of expansion of the drug. Shortly after the committee was set up due to the occurrence of adverse events, Gilead’s had to put on hold 6 clinical trials that were being conducted on the relapsed patient.
Gilead’s Zydelig will be facing some very serious competition with very effective, target specific, comparatively less harmful drugs specifically Johnson & Johnson’s and AbbVie star product Imbruvica which is getting one after other approvals for different form of cancer treatments.
Even though the drug received green signal for the use, there are too many obstacles to be crossed before Gilead’s Zydelig can securely establish itself in the market again.
Featured image credit: Gilead Sciences, ASSOCIATED PRESS