On Tuesday, Puma Biotechnology's (NASDAQ:PBYI) profile was bolstered following an endorsement from the National Comprehensive Cancer Network (NCCN), as it updated its Clinical Practice Guidelines in Oncology for Cervical Cancer to include Puma (OTC:PMMAF)'s Nerlynx as a treatment option. The recommendation by NCCN is specific for patients with HER2-mutated tumors to use Nerlynx for recurrent or metastatic disease as a second-line or subsequent therapy, with a Category 2A designation.
Nerlynx is Puma's marketed irreversible tyrosine kinase inhibitor, which is designed to block signal transduction through the epidermal growth factor receptors HER1, HER2, and HER4. It has already been approved in the U.S. for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, following adjuvant Herceptin-based therapy.
Moreover, Nerlynx is also sanctioned in combination with Xeloda for treating advanced or metastatic HER2-positive breast cancer patients who have undergone at least two prior anti-HER2-based regimens in a metastatic setting.
The NCCN guidelines had previously incorporated Nerlynx combinations as Category 2B potential targeted therapies for patients with ER-positive/HER2-negative or ER-negative/HER2-positive metastatic (stage IV) breast cancer with activating mutations in the HER2 gene, as detected by next-generation sequencing of tumor tissue or circulating tumor DNA (ctDNA). The recent inclusion of Nerlynx in the NCCN Guidelines for Cervical Cancer is grounded on results from Puma's Phase 2 SUMMIT trial.
According to the analyst from H.C. Wainwright, this new development could positively impact Nerlynx sales, although no changes to sales forecasts have been made at this time. Current estimates for net Nerlynx sales stand at $46.4 million for the fourth quarter of 2024, with projected net product sales of $187.2 million for the full year 2024 and $195.3 million for 2025. The firm maintains a "Buy" rating and a $7.00 price target on Puma Biotechnology shares.
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