FDA Approves Copanlisib for Certain Types of Follicular Lymphoma

The United States Food and Drug Administration (FDA) recently granted accelerated approval to copanlisib for treatment of adults with relapsed follicular lymphoma (FL) who have received at least two prior lines of therapy. Copanlisib is a kinase inhibitor that works by blocking some of the enzymes responsible for cancer cell growth.

The FDA’s decision is based on favorable safety and efficacy results in over 100 patients around the world as part of the CHRONOS-1 clinical trial.

Instead of having to wait years to learn whether a drug actually extends survival for cancer patients, accelerated approval enables the FDA to more quickly approve drugs that fulfill an unmet clinical need for serious conditions. Scientists look to measure surrogate or intermediate clinical endpoints – like tumor shrinkage, for example – that indicate whether a drug is reasonably likely to predict clinical benefit.

As a condition of accelerated approval, a randomized control (comparison) trial will be required to verify the clinical benefit of copanlisib before it can move on to help relapsed follicular lymphoma patients whose treatment options are often limited.

Dr. Peter Martin Describes a Copanlisib Trial for Mantle Cell Lymphoma Patients who have Previously Failed Ibrutinib Treatment

In this video Dr. Peter Martin describes the benefits of a recently opened clinical trial evaluating the efficacy and safety of copanlisib for mantle cell lymphoma (MCL) patients, who have failed or were unable to tolerate ibrutinib treatment. The purpose of this study is to to evaluate the efficacy and safety of copanlisib monotherapy in patients with MCL.

If you’re interested in participating in this trial please call 212-746-2919 for more information. A full listing of MCL trials at Weill Cornell Medicine can be found here.

New Clinical Trial: A Phase 2 Study to Evaluate the Efficacy & Safety of Copanlisib in Patients with Relapsed/Refractory MCL, who Failed Ibrutinib Treatment or Were Unable to Tolerate Ibrutinib

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with refractory MCL, who have failed ibrutinib treatment or were unable to tolerate ibrutinib. The study sponsor is the Bayer Corporation, and the principal investigator at Weill Cornell is Peter Martin M.D.. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women age 18 and older with histologically confirmed MCL.
  • Ibrutinib as the last anti-cancer treatment.
  • Availability of fresh tumor tissue.
  • Detailed eligibility reviewed when you contact the study team.

Study Summary 

This clinical trial is for men and women with mantle cell lymphoma (MCL) who were previously treated for this disease and who failed ibrutinib treatment or were unable to tolerate ibrutinib treatment.

While treatment of MCL with ibrutinib has yielded promising efficacy, clinicians and researchers are reporting the development of ibrutinib resistance. Clinically, ibrutinib resistance leaves MCL patients without an established recourse for further treatment. Offering a treatment targeting a different pathway provides an opportunity to fulfill an unmet medical need in this patient population. In addition, some patients are unable to tolerate ibrutinib treatment, leaving them without an established therapeutic option after first-line treatment failure.

This is a single-arm, open-label phase 2a study to evaluate the efficacy and safety of copanlisib monotherapy in patients with MCL, who failed ibrutinib treatment or were unable to tolerate ibrutinib. Patients will receive copanlisib IV infusion at a starting dose of 60 mg as single agent on Days 1, 8 and 15 of each 28-day treatment cycle. Patients will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects. All patients, except for patients who object to follow-up data collection, will be followed for overall survival at least every 3 months during the survival follow-up period until death or until the end of study, whichever occurs first.


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