Shots:
FDA approved Inluriyo (200mg; PO) for treating adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after ≥1L of endocrine therapy; US availability expected in the coming wks.
Approval was based on P-III (EMBER-3) trial (N=874: 32% in 1L & 64% in 2L treatment post progression) assessing Inluriyo ± abemaciclib vs fulvestrant/exemestane…
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Daiichi reported the first patient dosing in a P-III (DESTINY-Endometrial01) study evaluating ENHERTU (trastuzumab deruxtecan) + rilvegostomig or pembrolizumab vs Pt. chemotx. (carboplatin and paclitaxel) + pembrolizumab as 1L therapy, in HER2-expressing (IHC 3+/2+), pMMR advanced or recurrent endometrial cancer pts
The study is assessing the efficacy and safety of ENHERTU (5.4 mg/kg)…
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The EC has approved Jemperli + CT (carboplatin & paclitaxel) as a 1L treatment of primary advanced or recurrent endometrial cancer in adults eligible for systemic therapy
Approval was based on part 1 of P-III (RUBY) study assessing Jemperli + CT followed by Jemperli vs CT + PBO followed by PBO and part…
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The EMA approved 3 BLA while 4 New Chemical Entities in December 2023, leading to treatments for patients and advances in the healthcare industry
In December 2023, the major highlighted drugs were Jempreli to treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer and Zilbrysq for the treatment of Generalized Myasthenia Gravis
PharmaShots has compiled a list of a…
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The US FDA approved 5 NDAs and 2 BLA in July 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 76 novel products in 2023
In July 2023, the major highlights drugs were Beyfortus (nirsevimab) approval for the prevention of RSV lower respiratory tract disease in…

