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August

FDA Approves Dose Escalation Label Update for Puma Biotechnology’s NERLYNX® (neratinib) in HER2-Positive Early Stage and Metastatic Breast Cancer

FDA Approves Dose Escalation Label Update for Puma Biotechnology’s NERLYNX® (neratinib) in HER2-Positive Early Stage and Metastatic Breast Cancer

Dose escalation of NERLYNX therapy demonstrated improved management and prevention of Grade 3 diarrhea

LOS ANGELES, Calif., July 1, 2021 – Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved a labeling supplement to the U.S. Prescribing Information for NERLYNX® that incorporates the use of NERLYNX dose escalation as evaluated in the Phase II CONTROL Trial and the new 133 count commercial NERLYNX SKU. The new 133 count SKU, i.e., a bottle containing a four-week supply of 133 tablets, is aligned with the use of NERLYNX dose escalation and designed to better support patient needs. Read complete news release HERE.

View Prescribing Information.

Katie Edmiston

Katie Edmiston has blogged 140 posts