The full indication for the approval is for adults with relapsed follicular lymphoma who have received at least 2 previous systemic therapy treatments.
Copanlisib has also been granted Priority Review designation and Orphan Drug Designation.
Zydelig (idelalisib) – the first-in-class PI3k inhibitor – is approved for relapsed follicular lymphoma and also chronic lymphocytic leukaemia, but saw its commercial prospects scuppered a year ago after reports of serious side effects, and some deaths, in clinical trials involving treatment-naïve lymphoma and leukaemia patients. “Therapies need to be both effective and tolerable”, said Anas Younes, MD, of Memorial Sloan Kettering Cancer Center, New York, in a press release. The study evaluated the number of patients experiencing partial or complete shrinkage of their tumors after treatment.
Accelerated Approval was granted to Bayer Healthcare Pharmaceuticals’ Aliqopa (copanlisib) today for the treatment of follicular lymphoma.
Aliqopa received an accelerated approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients. The overall response rate was 59% (95% CI, 49%-68%), with 14% of patients achieving a complete response. “We are pleased that the FDA has recognised the promising results of the CHRONOS-1 trial and look forward to offering this important new treatment option to patients with lymphoma, who now have a high unmet need for effective therapies”.
Meawhile, Bayer is also developing its drug for breast cancer and other solid tumours, but in the non-haematological sphere Novartis’ P13K alpha inhibitor alpelisib is in pole position, with phase III trials for breast cancer and phase II in non-small cell lung cancer (NSCLC) with a filing due in 2019.
Common side effects of the treatment include hyperglycemia, diarrhea, decreased general strength and energy, hypertension, low levels of certain white blood cells and thrombocytopenia.