e="text-align: center;">The FDA OKs Bayer Cancer Drug For Relapsed Follicular Lymphoma
The FDA has approved Bayer’s copanlisib, which will now be marketed as Aliqopa for relapsed follicular lymphoma. The cancer drug has been given a conditional green light as a third-line treatment for patients with relapsed or refractory follicular lymphoma, the most common type of non-Hodgkin’s lymphoma (NHL), and Bayer has committed to carrying out additional studies to confirm its benefits in this setting.
Follicular lymphoma is a slow-growing type of non-Hodgkin lymphoma, a cancer of the lymph system. The lymph system is part of the body’s immune system and is made up of lymph tissue, lymph nodes, the spleen, thymus, tonsils and bone marrow. The National Cancer Institute at the National Insititutes of Health estimates that approximately 72,240 people in the United States will be diagnosed with some form of non-Hodgkin lymphoma this year; approximately 20,140 patients with non-Hodgkin lymphoma will die from the disease in 2017.
“Before the approval of Aliqopa, doctors and patients facing follicular lymphoma, a very serious and difficult-to-treat blood cancer, have had a need for new and effective options when patients relapse,” said Carsten Brunn, head of Bayer Pharmaceuticals in the Americas, in a statement.
“The FDA’s accelerated approval of this important treatment reflects Bayer’s commitment to delivering new treatment options, and we commend the FDA on its speedy review and ongoing dedication to innovation in areas of great unmet medical need.”
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 last year after reports of serious side effects, and some deaths, in clinical trials involving treatment-naïve lymphoma and leukaemia patients.
Zydelig is an oral therapy, while Aliqopa is given as a one-hour infusion on an intermittent weekly basis – three weeks on and one week off, but Bayer says that in this patient group that is not an impediment and actually fits in well with care of these patients.
The approval was based on data from a single-arm trial that included 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least two prior treatments. The trial measured how many patients experienced complete or partial shrinkage of their tumors after treatment (overall response rate). In the trial, 59 percent of patients had a complete or partial response for a median 12.2 months.
Aliqopa was granted Priority Review designation, under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition. The drug has also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
