Bayer Receives Accelerated Approval for Aliqopa

On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Aliqopa to Bayer Healthcare Pharmaceuticals, Inc., for the treatment of relapsed follicular lymphoma. The FDA granted Aliqopa under Accelerated Approval, Priority Review, and Orphan Drug designations. These designations indicate that Aliqopa is a drug for treating serious conditions, fills an unmet medical need, and provides incentives to encourage the development of drugs for rare diseases.

Follicular lymphoma is a type of blood cancer, and is the most common of the slow growing type of non-Hodgkin’s lymphomas. The National Cancer Institute estimates 72,240 new cases of follicular lymphoma in the United States in 2017, and 20,140 deaths from follicular lymphoma.^[1]

Aliqopa (copanlisib; 2-Amino-N-[7-methoxy-8-(3-morpholin-4-ylpropoxy)-2,3-dihydroimidazo[1,2-c]quinazolin-5-yl]pyrimidine-5-carboxamide; chemical formula shown below) is an intravenous selective class I phosphoinositide 3-kinase inhibitor (PI3K inhibitor), primarily inhibiting PI3K-α and PI3K-δ isoforms. Aliqopa induces tumor cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines. Aliqopa inhibits several cell-signaling pathways, including B-cell receptor signaling, CXCR12 mediated chemotaxis of malignant B cells, and NFκB signaling in lymphoma cell lines.

Aliqopa demonstrated a clinically meaningful response in patients with follicular lymphoma who had relapsed disease following at least two prior treatments.

According to a Bayer press release, the “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.” Bayer anticipates immediate release of Aliqopa in the U.S. market.