U.S. Food and Drug Administration Approves Puma’s NERLYNX™ (neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer
Puma Biotechnology Inc (PBYI)
Last puma biotechnology inc earnings: 2/20 04:07 pm
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Source: Business Wire
Neratinib becomes the first anti-HER2 treatment to be FDA-approved as extended adjuvant therapy for early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy. Treatment with neratinib resulted in a 34% reduction in the risk of invasive disease recurrence or death versus placebo after patients completed one year of therapy following a trastuzumab-based regimen. Neratinib addresses an unmet medical need, as up to 25% of HER2-positive early-stage breast cancer patients treated with trastuzumab-based adjuvant treatment experience a recurrence. LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (Nasdaq: PBYI) today announced that the U.S. Food and Drug Administration (FDA) has approved NERLYNX™ (neratinib), formerly known as PB272, a once-daily oral tyrosine kinase inhibitor for the extended adjuvant treatment of adult patients w
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News
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PBYI
Earnings
- 2/29/24 - Miss
PBYI
Analyst Actions
- 2/13/24 - HC Wainwright
PBYI
Sec Filings
- 4/26/24 - Form DEFA14A
- 4/26/24 - Form ARS
- 4/26/24 - Form DEF
- PBYI's page on the SEC website