Bayer’s Aliqopa Receives Breakthrough Therapy Status for Marginal Zone Lymphoma

According to a publication from Benzinga, the U.S. Food and Drug Administration has granted Breakthrough Therapy status to Bayer’s relapsed follicular lymphoma drug Aliqopa (copanlisib) for the treatment of marginal zone lymphoma, a different form of non-Hodgkin’s Lymphoma.

About Marginal Zone Lymphoma

Marginal zone lymphoma (MZL) is a form of B-cell Non-Hodgkin’s lymphoma, a type of cancer that originates in the lymphatic system, which is a major component of the immune system that extends throughout the body in a web not dissimilar from the vascular or nervous systems.

B-cell lymphomas originate, as their name implies, in B cells – a type of white blood cell that fight infection by producing antibodies that neutralize and destroy pathogenic molecules.

Marginal zone lymphomas are characteristically slow-progressing; apart from irregularities in the lymph nodes, patients with MZL often have no other symptoms at the time of diagnosis. About 10% of Non-Hodgkin’s lymphoma diagnoses are cases of MZL.

Aliqopa Granted Breakthrough Therapy Status for MZL

Aliqopa, Bayer’s branded version of the generic drug copanlisib, was first approved by the FDA in late 2017 for the treatment of relapsed follicular lymphoma. The drug was fast-tracked after a particularly successful phase II study that brought about dramatic improvements in follicular lymphoma patients who were non-responsive to at least two other systemic therapies. Overall response rate was so high, and with such a low risk of side-effect, that Aliqopa was approved much earlier in the clinical process than it normally would be.

Marginal zone lymphoma is, in some ways, similar to follicular lymphoma – both are slow-progressing Non-Hodgkin’s lymphomas. In the same phase II study, an arm of patients with MZL also responded positively to doses of Aliqopa. These findings were similarly the basis of Aliqopa’s recent Breakthrough Therapy Designation.

About Breakthrough Therapies

Breakthrough therapy designation is one of the several statuses the FDA can grant experimental drugs or therapies to expedite or incentivize certain developments.

A number of benefits are made available to drugs designated to be “breakthrough therapies,” including full eligibility for Fast Track designation. The FDA might also offer the proprietor streamlining recommendations to maximize the efficiency of a clinical study.

Bayer has announced intentions for two additional phase III studies designed to evaluate the safety and effectiveness of Aliqopa as a single component in different combination therapies.


“Drug repositioning” is a scientific methodology that tries to find new uses for existing drugs. Drugs that are “repositioned” can cost a fraction of ground-up drug development, and with greater efficiency. Do you think drug repositioning should be a more common method of drug development? Do you think this model has problems? Share your thoughts with Patient Worthy!

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