Sun Pharma Advanced Research Company application for cancer drug Taclantis denied by USFDA
New Delhi: Sun Pharma Advanced Research Company Ltd on Tuesday said the USFDA has ruled against its appeal related to Taclantis, its under development product for treatment of breast cancer.
The Office of New Drugs (OND) of the US Food and Drug Administration (FDA) has denied the company''s appeal of the Complete Response Letter (CRL) in relation to the New Drug Application (NDA) for Taclantis, Sun Pharma Advanced Research Company (SPARC) said in a regulatory filing.
In its letter, the OND requested the conduct of a new Phase 3 study in metastatic breast cancer patients to support any potential resubmission of the Taclantis NDA, it added.
The company will review FDA''s response and decide on appropriate next steps soon, SPARC noted.
As per the USFDA, a CRL is sent to an applicant if the agency determines that it will not approve the application or abbreviated application in its present form.
On July 1, 2019, the company had announced that the USFDA had accepted for review SPARC''s NDA for Taclantis.
The company''s NDA filing was based on successful demonstration of clinical bioequivalence of Taclantis with Abraxane and associated clinical safety data.
Abraxane is indicated for treatment of breast cancer, lung cancer, among others.
In 2017, USFDA had denied approval to SPARC''s new drug application for Elepsia XR, an anti-epileptic drug.