Bayer lymphoma treatment speeds to FDA approval

The FDA gave Bayer priority review for its treatment Aliqopa (copanlisib) in May of this year, and it quickly came to the judgement that the drug should be brought to patients with relapsed follicular lymphoma.

The drug will be made available to patients who have received two prior systemic therapies and the accelerated approval was based on Phase 2 trial data. The trial involved 104 patients, of which 59% achieved an objective response rate, with 14% achieving a complete response, and a median duration of response of 12.2 months.

In a major boost to the drug, serious adverse reactions were limited to 26% of the patient group. The limited number of events is in stark contrast to rival in this area, Gilead’s Zydelig that has been hindered by a rash of serious adverse events and isolated deaths in clinical trials.

This means that Aliqopa is expected to enter the market as a strong competitor to Gilead’s drug, more than likely overtaking the floundering sales of the rival treatment. The approval could be worth around $600 million in peak sales to Bayer, with the potential to expand the indication of the drug into second-line treatment.

"Today's approval of copanlisib marks an important advance in the development of new treatment options for adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies," said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. "This approval provides another option for patients; we commend the patients and investigators who enable research such as this to continue to push forward to ultimately move closer to finding a cure."

The PI3K inhibitor is also being explored as a treatment for relapsed or refractory diffuse B-cell lymphoma.