Genentech's Biologic Kadcyla (Trastuzumab Emtansine) Receives Approval in U.S.
MALVERN, Pa. & SAN DIEGO--(BUSINESS WIRE)--PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced the appointment of Jonathan J. Birchall as Chief Commercial Officer.
Cariprazine, the Allergan-turned-AbbVie drug for bipolar depression and schizophrenia, had a rocky road through clinical trials before its approvals. And as AbbVie attempts to further expand into major depressive disorder, it’s facing similar challenges.
The British Columbia-based biotech revealed its XEN1101 program passed a Phase IIb test at all three doses, producing highly statistically significant results at the mid-and high-dose levels. There’s no concrete plan yet to commercialize the drug, as Xenon still needs to meet with the FDA, but the biotech noted it expanded the study’s open-label extension to three years to obtain more follow-up data. In response to the news, Xenon shares $XENE were trading higher by as much as 85% pre-market Tuesday. After the opening bell, Xenon stock was up by about 75% in early trading.
The FDA has granted breakthrough designation to AstraZeneca’s and Daiichi Sankyo’s HER2 ADC Enhertu, the companies jointly announced today.
AstraZeneca and Daiichi Sankyo's Enhertu delivered a massive advantage over Roche's rival antibody-drug conjugate Kadcyla at slowing tumor progression in HER2-positive breast cancer. Biogen and Samsung Bioepis snagged an FDA nod for the U.S.' first ophthalmology biosimilar, a copycat referencing Roche and Novartis' Lucentis. With positive efficacy data, Clover Biopharmaceuticals will seek China, EU and World Health Organization authorizations for its COVID-19 vaccine.
Pharma watchers have always suspected that AstraZeneca and Daiichi Sankyo’s Enhertu is a better HER2 therapy than Roche’s Kadcyla. But guessing is all they could do without a head-to-head trial to show just how different the two antibody-drug conjugates are.
Genentech's Biological Ado-Trastuzumab Emtansine Receives Approval In US
Kadcyla obtained an additional indication of HER2-positive postoperative early breast cancer, in addition to the indication of HER2-positive inoperable or recurrent breast cancer.nKadcyla is a postoperative new treatment option to improve prognosis in the treatment of HER2-positive early breast cancer when pathologic complete response (pCR) is not obtained by neoadjuvant therapy.
Chugai Pharmaceutical announced that it has obtained approval for anti-HER2 antibody-tubulin polymerization inhibitor conjugate Kadcyla Intravenous Infusion 100 mg and 160 mg [trastuzumab emtansine (genetical recombination)] from the Ministry of Health, Labour and Welfare of Japan for an additional indication of HER2-positive postoperative breast cancer.