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The P-III (SERENA-6) trial assessed camizestrant + CDK4/6 inhibitor (palbociclib/ribociclib/abemaciclib) vs AI (anastrozole/letrozole) + CDK4/6 inhibitor in 315 pts with LA/M HR+/HER2- breast cancer harboring ESR1 mutation
SERENA-6 used ctDNA-guided approach to monitor ESR1 mutations at routine scans for the early detection of endocrine resistance, allowing pts to switch to camizestrant before disease…
Shots:
A UK observational study spanning 17 years shows a 2.9-fold increase in Cardiac Amyloidosis diagnoses, highlighting significant progress in awareness among healthcare professionals and advancements in diagnostic tools
The study underscores the importance of improving the identification and treatment of Cardiac Amyloidosis, particularly in cases with overlapping conditions such as heart failure
Mina Makar,…
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AstraZeneca has purchased FibroGen’s China subsidiary for ~$160M ($85M enterprise value + ~$75M net cash) with closing expected in mid-2025, obtaining full rights to roxadustat in China
The sale allows FibroGen to repay its Morgan Stanley Tactical Value loan & extend its cash runway to 2027 for advancing FG-3246 in P-II trial for…
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The P-III (NIAGARA) trial assessed Imfinzi (4 cycles + neoadj. CT; then 8 cycles alone) vs CT with surgery in MIBC pts ± pCR; ongoing regulatory review in the US, EU, Japan & other areas
Trial met its 2EPs of improved MFS (75.1% vs 65.1%) & DSS (89.2% vs 82.2%) in ITT pts (N=1063)…
Shots:
PharmaShots has compiled a list of US FDA-approved drugs in the month of January 2025
The US FDA has approved a total of 3 new drug including 2 new molecular entities and 1 biologic leading to the treatment of patients and advances in the healthcare industry
The major highlighted drug was Daiichi Sankyo &…
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The CHMP has recommended Imfinzi for the treatment of LS-SCLC pts whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions
Opinion was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by Imfinzi…
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The CHMP has recommended Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in pts receiving endocrine-based therapy & CT. Ongoing regulatory review in China & other regions
Opinion was supported by a global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D) vs single agent…
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Daiichi & AstraZeneca have dosed first patient with adj. Datroway (6 mg/kg) + rilvegostomig/ rilvegostomig monotx. (750mg) in P-III (TROPION-Lung12) trial to treat stage 1a/1b adenocarcinoma NSCLC (tumors <4 cm) after complete tumor resection who are ctDNA+ or exhibit high-risk of relapse
Study will evaluate DFS as the 1EP, while OS, safety, patient-reported…
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The US FDA’s approval of Enhertu for HR+, HER2 low/ultralow MBC, progressed on endocrine therapies, was based on P-III (DESTINY-Breast06) study compared to CT shared at ASCO 2024 & published in The NEJM. AZ will pay $175M for this milestone
Study depicted PFS of 36%, mPFS of 13.2 vs 8.1mos., cORR of 62.6%…
Shots:
The 43rd Annual J.P. Morgan Conference took place from 13th to 16th January in San Francisco, USA. J.P. Morgan Healthcare Conference serves as a pioneering hub that features presentations and dialogues on the advances of the healthcare industry by bringing healthcare professionals, researchers, manufacturers, and other healthcare stakeholders to one platform.
Innovation remained the…

