Jazz Pharmaceuticals at ASCO 2025: Robert lannone in an Illuminating Conversation with PharmaShots

Daiichi Sankyo’s Datroway (Datopotamab Deruxtecan) Receives the NMPA’s Approval for Unresectable or Recurrent HR+/HER2- Breast Cancer

Shots: China’s NMPA has approved Datroway for treating adults with HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) inoperable or recurrent breast cancer after previous CT Approval was based on P-III (TROPION-Breast01) study assessing Datroway (6mg/kg, IV, Q21D) vs single-agent CT in adults (n=732) with HR+/HER2- metastatic breast cancer Study showed improved PFS by 37%…

Eisai and Biogen Report EU Launch of Leqembi (Lecanemab) to Treat Alzheimer’s Disease

Shots: Eisai & Biogen have reported EU launch of Leqembi, starting with Austria on Aug 25, 2025 & Germany on Sep 1, 2025, following EC approval in Apr 2025 Approval was based on the P-III (Clarity AD) trial assessing Leqembi (n=757) vs PBO (n=764) in pts with MCI or mild dementia due to AD &…

Daiichi Sankyo Reports the MHLW’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots: Japan’s MHLW has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy Approval was based on the P-III (DESTINY-Breast06) trial (N=866) assessing Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=152) pts Trial showed 38% PFS in CT-naïve HER2-low pts & mPFS of 13.2…

argenx Reports Topline P-III (ADAPT SERON) Trial Data of Vyvgart for AChR-Ab Seronegative Generalized Myasthenia Gravis

Shots: argenx has reported topline P-III (ADAPT SERON) trial data on Vyvgart (efgartigimod alfa; IV) for AChR-Ab seronegative generalized myasthenia gravis (gMG) Trial (n=119) consist of 2 Parts: Part A assessed Vyvgart (QW × 4wks.) vs PBO, followed by 5wk. follow-up, while Part B was an OLE study, where pts received 2 fixed cycles of…

Health Canada Approves Roche’s Columvi (Glofitamab) Combination to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Shots: Health Canada has approved Columvi + GemOx for the treatment of ASCT-ineligible pts with r/r diffuse large b-cell lymphoma (DLBCL) Approval was based on P-III (STARGLO) study of Columvi + GemOx vs MabThera/Rituxan + GemOx for r/r DLBCL At mFU of 11.3mos., the trial met its 1EP of OS, reducing the death risk by…

Bayer Reports Health Canada’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: Health Canada has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT vs PBO + ADT in 669 mHSPC pts Trial showed a 46% reduction in rPFS (1EP), with consistent benefit observed across all subgroups, incl. pts…

AbbVie Reports Topline P-III (UP-AA) Trial Data on Rinvoq (Upadacitinib) to Treat Alopecia Areata

Shots: AbbVie has reported topline P-III (UP-AA) trial data on Rinvoq (QD) for sev. alopecia areata in pts with a mean baseline SALT score of 84 Trial incl. 2 replicate studies (Study 1 & 2) in AA pts (n=1399; 12-64yrs.), where in both studies' Period A, pts were randomized to Rinvoq 15mg, 30mg, or PBO…

Ionis Reports the US FDA’s Approval of Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: The US FDA has approved Dawnzera (donidalorsen; 80mg SC, Q4W/Q8W) as a prophylactic treatment against attacks in pts (≥12yrs.) with hereditary angioedema; available in the US in coming days Approval was based on P-III (OASIS-HAE) trial & OASISplus OLE study, where P-III showed 81% fewer monthly HAE attacks over 24wks. (87% from 2nd dose) &…