Bayer’s lymphoma treatment gains FDA Breakthrough Therapy Designation
FDA has given Breakthrough Therapy Designation to Bayer’s PI3K inhibitor Copanlisib for marginal zone lymphoma (MZL) patients who have received two prior therapies.
MZL is an indolent form of non-Hodgkin’s Lymphoma (iNHL) and accounts for approximately 10% of all non-Hodgkin’s Lymphoma cases in the US.
The designation was based on data from a MZL subgroup of the CHRONOS-1 trial, which Bayer used to get approval for the drug in follicular lymphoma.
The approval for follicular lymphoma marks Bayer’s first entry into the haemato-oncology market. Although in this indication it faces tough competition from drugs like Johnson & Johnson’s BTK inhibitor ibrutinib, Roche’s anti-CD20 Obinutuzumab and Gilead’s own PI3K inhibitor Idelalisib.
Evaluate Pharma has predicted sales of around $262 million for Copanlisib by 2022.
Getting PI3K drugs to work with tolerable side effects has been difficult, for instance Gilead’s Idelalisib is used in leukaemia but has boxed warnings due to its side effects.
In addition to this, Roche discarded its PI3K drug taselisib last year after deciding that the side effects outweighed the drug’s modest benefits in a phase 3 breast cancer trial.
Bayer is conducting two additional Phase III studies – CHRONOS-3 and CHRONOS-4 – to evaluate the efficacy and safety of copanlisib in combination with other therapies in iNHL (including MZL) patients who have relapsed following one or more prior therapies.
“The clinical evidence suggests that copanlisib may address an unmet medical need by providing physicians and MZL patients with a therapy in a relapsed setting where there are no approved treatments,” said Scott Fields, senior vice president and head of oncology development at Bayer’s Pharmaceutical Division. “We will continue working closely with the FDA in order to bring copanlisib to these underserved patients as soon as possible.”
Earlier this week Novartis became the first company to get a PI3K inhibitor approved in advanced breast cancer with its drug Alpelisib.