On January 3, 2023 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that its proprietary Oral Paclitaxel formulation did not receive regulatory approval from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) for metastatic breast cancer based solely on CMC issues (Press release, Athenex, JAN 3, 2023, View Source [SID1234625721]). The MHRA application was not rejected based on any clinical efficacy or safety concerns expressed by the MHRA. MHRA regulations allow an applicant to request a re-examination of an opinion by an independent board which the Company plans to pursue. The Company views the identified CMC issues as addressable.
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"While we are disappointed by the MHRA decision, we are encouraged that we have satisfactorily addressed any major concerns related to the clinical efficacy and safety of Oral Paclitaxel. We believe the iSPY 2 study is an important data set that further characterizes the safety profile of Oral Paclitaxel and we plan to amend our metastatic breast cancer NDA with the iSPY 2 safety data this quarter," said Dr. Johnson Lau, Chief Executive Officer of Athenex. "To maximize the value of Oral Paclitaxel, we expect to re-engage the FDA by amending our metastatic breast cancer NDA with the iSPY 2 data, and pursue opportunities to advance development of Oral Paclitaxel in the neoadjuvant breast cancer setting in light of recent graduation of Oral Paclitaxel from the iSPY 2 program."