Puma Biotechnology announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion, recommending the refusal of the Marketing Authorisation Application (MAA) for neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer.
On January 23, 2018, Puma announced that the CHMP had communicated a negative trend vote after meeting with the Company to discuss the MAA and that a negative trend vote meant it was unlikely that CHMP would provide a positive opinion related to the Company’s MAA at the formal CHMP meeting. The CHMP has noted that Puma may request a re-examination of the opinion and that a letter of intent to seek re-examination should be submitted within 15 days of acknowledgement of receipt of the final opinion package. Puma plans to submit this request in accordance with this timeline.
CHMP’s vote was based on the results from both the Phase III ExteNET trial in extended adjuvant early stage HER2-positive breast cancer and the Phase II CONTROL trial in extended adjuvant early stage HER2-positive breast cancer.
Puma Biotechnology, headquartered in Los Angeles, USA, is a development stage biopharmaceutical company dedicated to in-licensing and developing novel therapeutics for the treatment of cancer.