The recent first global approval of copanlisib has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2].

In September 2017, copanlisib (Aliqopa™) developed by Bayer Healthcare, received its first global approval in the US for for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies[3]. This was an accelerated approval granted by the FDA based on results from an open-label, single arm phase II study in 104 patients (CHRONOS-1). A condition of the approval requires that a randomised controlled study be completed to verify the clinical benefit of the agent [3].

Copanlisib is administered as an intravenous infusion and is a highly selective and potent pan-class I phosphatidylinositol 3-kinase inhibitor (PI3K), that has particular activity against the α- and δ-isoforms. [1] [2]   Activation of class I PI3Ks has been associated with resistance to targeted cancer treatments including trastuzumab and imatininb.

Follicular lymphoma is estimated to contribute 20% to all cases of non-Hodgkin lymphoma (NHL)[4]. More than 72,000 new cases of NHL were predicted in 2017 in the US.

Copanlisib was granted orphan drug and fast track designation; it is the only approved PI3K inhibitor that is predominantly active against the alpha and delta isoforms and the only one to be given as an intermittent intravenous regimen[5].

“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, Americas Region[5]

Dr. Anas Younes, Medical Oncologist and Chief of Lymphoma Service at Memorial Sloan Kettering Cancer Center agreed as he highlighted the challenge for physicians when he stated that, “two factors for physicians involve lessening tumor burden and reducing adverse events patients may experience from treatments. Therapies need to be both effective and tolerable,” he went on to explain that, “The PI3K pathway is activated in many tumor types, including lymphoma, and targeting PI3K therapeutically is a very important strategy in this area of disease. Copanlisib has a safety and efficacy profile that is a welcome advance for both doctors and patients in third-line follicular lymphoma.” [5]

Late stage clinical development for copanlisib is underway worldwide, in patients with non-Hodgkin’s lymphoma. Clinical development is underway in several countries worldwide, for the treatment of diffuse large B-cell lymphoma, cholangiocarcinoma, endometrial cancer, breast cancer and advanced solid tumours[2].

According to the prescribing information, Warnings and Precautions for copanlisib include, infections, hyperglycemia, hypertension, non-infectious pneumonitis (NIP), neutropenia, cutaneous reactions, and embryo-fetal toxicity[6].

For further information related to the first approval of copanlisib please visit Drugs[1],  or to learn more about the overall development of copanlisib across all indications visit AdisInsight[2].

Credit: zlikovec/Fotolia

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