Based on promising responses seen across several clinical trials of poziotinib in patients with non–small cell lung cancer and exon 20 mutations in HER2, the FDA granted the therapy fast track designation.
The investigational epidermal growth factor inhibitor poziotinib was granted fast track designation by the FDA as therapy for patients with non–small cell lung cancer (NSCLC) whose tumors harbored HER2 exon 20 mutations, according to Spectrum Pharmaceuticals who is responsible for developing the agent.1
This designation is granted to medications in order to facilitate and expedite their development and review to become available to treat patients who might not otherwise have a viable systemic therapy option.
“There are currently no approved therapies to treat patients with HER2 exon 20 mutations and we are pleased that the FDA has granted fast track designation for poziotinib,” Joe Turgeon, President and CEO of Spectrum Pharmaceuticals, said in a press release. “Momentum is building to unlock the potential of poziotinib.”
Previously, a single-center trial (NCT03066206) conducted at MD Anderson Cancer Center showed a higher rate of confirmed responses at 43% in patients with heavily pretreated EGFR or HER2 exon 20–mutant disease who received poziotinib therapy. Responses were seen regardless of if patients were refractory or naïve to therapy with other tyrosine kinase inhibitors.2
A recent presentation at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021 held March 1-2, 2021, detailed the results of 2 cohorts explored in the ZENITH20 trial (NCT03318939) of poziotinib in patients with NSCLC and mutations in exon 20 in either EGFR and HER2. Cohorts 2 and 4 of the trial are specifically for the assessment of patients with HER2 exon 20 mutations and previously treated or treatment-naïve disease, respectively, with the latter still open to enrollment. The primary end point of the trial is objective response rate with secondary outcomes of disease control rate, duration of response, and progression-free survival.3
Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use,
BioPharma Global is a mission-driven corporation, operating like a not-for-profit, dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a high unmet medical need. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.
Stock image by @tatsianama from Depositphotos