Brief: Athenex Receives FDA Complete Response Letter For Metastatic Breast Cancer Treatment

Athenex

01/03/2021 12:56

March 1 (Reuters) - Athenex Inc  ATNX.O :
    * ATHENEX RECEIVES FDA COMPLETE RESPONSE LETTER FOR ORAL
PACLITAXEL PLUS ENCEQUIDAR FOR THE TREATMENT OF METASTATIC
BREAST CANCER
    * ATHENEX - FDA INDICATED CONCERN OF SAFETY RISK TO PATIENTS
IN
TERMS OF RISE IN NEUTROPENIA-RELATED SEQUELAE ON ORAL PACLITAXEL
ARM VERSUS IV PACLITAXEL ARM
    * ATHENEX - FDA EXPRESSED CONCERNS REGARDING UNCERTAINTY
OVER
RESULTS OF PRIMARY ENDPOINT ORR AT WEEK 19 CONDUCTED BY BLINDED
INDEPENDENT CENTRAL REVIEW
    * ATHENEX INC - FDA STATED THAT BICR RECONCILIATION AND
RE-READ
PROCESS MAY HAVE INTRODUCED UNMEASURED BIAS AND INFLUENCE ON
BICR
    * ATHENEX - FDA RECOMMENDED CO CONDUCT NEW ADEQUATE,
WELL-CONDUCTED CLINICAL TRIAL IN PATIENTS WITH METASTATIC BREAST
CANCER REPRESENTATIVE OF U.S. POPULATION
    * ATHENEX - PLANS TO REQUEST MEETING WITH FDA TO DISCUSS
RESPONSE,
ENGAGE IN DIALOGUE ON DESIGN & SCOPE OF CLINICAL TRIAL TO
ADDRESS FDA'S REQUIREMENTS
    * ATHENEX - FDA DETERMINED ADDITIONAL RISK MITIGATION
STRATEGIES
TO IMPROVE TOXICITY ARE REQUIRED TO SUPPORT POTENTIAL APPROVAL
OF NDA
    * ATHENEX INC - WILL IDENTIFY AND UNDERTAKE APPROPRIATE
INTERNAL
ORGANIZATIONAL ADJUSTMENTS

Source text for Eikon:  ID:nGNX7hXnMr 
Further company coverage:  ATNX.O 

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