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FDA Approves Dose Labelling For NERLYNX®

Puma Biotechnology, Inc., Los Angeles based biopharmaceutical company, has announced that the United States Food and Drug Administration (FDA) approved a labeling supplement regulating the U.S. Prescribing Information for NERLYNX® incorporating the approval of dose escalation, which was examined during the Phase 2 CONTROL Trial along with the latest 133 count commercial  SKU.

The new candidate 133 counts SKU is a bottle satisfying four-week supply with 133 tablets, aligned with the utilization of  dose-escalation designed in a way that is best supports patient needs. The CONTROL trial was an open-label well informed, a multi-cohort study assessing the patients diagnosed with early HER2-positive breast cancer treated with the new NERLYNX® 240mg dose on a daily basis for a span of one year.

Patients were provided with loperamide prophylaxis along with additional anti-diarrheal treatment based on the needs or a treatment combining dose escalation with Loperamide as per requirements.Patients participating in the dose-escalation cohort were given NERLYNX® 120 mg regularly for the first week of trial, followed by a dose of 160 mg every day for week two (2) and next dose scalation receiving NERLYNX® 240 mg daily for the third week continued for the rest of the treatment span.

Trial data presented that dose escalation cohort coupled with PRN loperamide, resulted in more than 60% decline in the percentage of patients experiencing Grade 3 diarrhea and a 50% reduction in the median cumulative days of the condition resulting in 5 days versus 2.5 days.

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