Bayer Withdraws Aliqopa NDA for Follicular Lymphoma After Trial Fails

In 2017, following data from the Phase 2 CHRONOS-1 study, the U.S. Food and Drug Administration (FDA) granted Accelerated Approval to Aliqopa (copanlisib) for adults living with relapsed follicular lymphoma. Aliqopa seemed like it could have potential benefits for people with follicular lymphoma who had already received two or more systemic therapies that, unfortunately, had not been effective.

The FDA asked Bayer, the drug’s developer, to validate the clinical benefit of Aliqopa in the Phase 3 CHRONOS-4 study. The CHRONOS-4 study sought to examine the safety, efficacy, and tolerability of Aliqopa – in conjunction with chemotherapy – for indolent non-Hodgkin’s lymphoma (NHL). Follicular lymphoma is one form of NHL. 547 participants enrolled in the study.

However, the trial failed to meet its primary endpoint, which was progression-free survival (PFS) compared with immunochemotherapy on its own. This means that Aliqopa with chemotherapy did not show any benefit in increasing how long someone lives without their cancer progressing when compared to immunotherapy. After talking with the FDA, Bayer has chosen to withdraw the Aliqopa New Drug Application (NDA) in the United States.

Moving forward, Bayer urges anybody who is currently using Aliqopa to speak with their doctors about what to do next. The company also shares that it hopes to figure out a way to ensure access to people for whom Aliqoba has been positive.

About Follicular Lymphoma

Follicular lymphoma is a slow-growing (indolent) form of non-Hodgkin’s lymphoma. This blood cancer develops when white blood cells called lymphocytes become cancerous and grow out of control. Follicular lymphoma is the most common form of NHL and occurs, most often, in people ages 60 or older. It is rare for younger individuals to develop this cancer. While this cancer responds well to treatment, it can be difficult to cure. Treatment options include chemotherapy, targeted therapy, and radiotherapy.

Symptoms related to follicular lymphoma can include:

  • Swollen lymph nodes in the neck, groin, underarms, or abdomen
  • Unintentional weight loss
  • Fever and drenching night sweats
  • Frequent infections or problems getting over infections
  • Fatigue
  • Shortness of breath

In rarer cases, people may develop anemia (low red blood cell count), thrombocytopenia (low platelet count), neutropenia (low white blood cell count), or even a transformed lymphoma, which is more aggressive.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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