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Secura Bio Announces U.S. Withdrawal of FARYDAK ® (panobinostat) NDA


SUMMERLIN, Nev., Nov. 30, 2021 /PRNewswire/ -- Secura Bio, Inc. (Secura Bio) - (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, announced today that, based on discussions with the U.S. Food and Drug Administration (FDA), Secura Bio has submitted to FDA for the withdrawal of the approval of NDA 205353 for FARYDAK® (panobinostat) oral capsules.  FARYDAK received accelerated approval in February 2015 for use in combination with bortezomib and dexamethasone to treat patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory agent.  Secura Bio acquired FARYDAK in March 2019.

The accelerated approval was based on progression-free survival and consistent with FDA regulations, required further adequate and well-controlled clinical studies to verify and describe the product's clinical benefit.  In its withdrawal submission, Secura Bio noted that, as previously discussed with FDA, it was not feasible for the company to complete the required post-approval clinical studies as designed as part of the accelerated approval process.  Because those studies were required to verify and describe the clinical benefit of the drug product, the clinical benefit of FARYDAK has not been confirmed under the specific constraints of the accelerated approval process.     

Because of the withdrawal submission, FARYDAK will no longer be discussed at the December 2, 2021 meeting of the Oncologic Drugs Advisory Committee.  As provided for by FDA regulations, Secura Bio anticipates FDA publishing a Federal Register notice announcing withdrawal of the approval.

Secura Bio and its partners will continue to market FARYDAK in other markets where it has been approved.

About FARYDAK (panobinostat)

INDICATION

FARYDAK® (panobinostat) capsules, a histone deacetylase inhibitor, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials

IMPORTANT SAFETY INFORMATION

WARNING: FATAL AND SERIOUS TOXICITIES: SEVERE DIARRHEA AND CARDIAC TOXICITIES

Severe diarrhea occurred in 25% of FARYDAK treated patients. Monitor for symptoms, institute anti-diarrheal treatment, interrupt FARYDAK and then reduce dose or discontinue FARYDAK.

Severe and fatal cardiac ischemic events, severe arrhythmias, and ECG changes have occurred in patients receiving FARYDAK. Arrhythmias may be exacerbated by electrolyte abnormalities. Obtain ECG and electrolytes at baseline and periodically during treatment as clinically indicated.

Diarrhea

Cardiac Toxicities

Hemorrhage

Myelosuppression

Infections

Hepatotoxicity

Embryo-Fetal Toxicity

DRUG INTERACTIONS

ADVERSE REACTIONS

Please see full Prescribing Information, including Boxed WARNING, for FARYDAK® (panobinostat) capsules.

Velcade® is a registered trademark of Takada Pharmaceutical Company Ltd.

About Secura Bio, Inc.

Secura Bio is an integrated, commercial-stage pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies for physicians and their patients.  For more information on Secura Bio, please visit www.securabio.com.

SOURCE Secura Bio, Inc.


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News published on 30 november 2021 at 16:45 and distributed by: