Shots:AstraZeneca has reported P-III (NATRON) trial data assessing Fasenra (30mg, SC, Q4W) vs PBO, both in addition to background HES therapy in 133 HES pts for 24wks.Trial met its 1EP of delayed time to first HES worsening or flare & reduced the risk of HES worsening/flare by 65%Trial met all 2EPs, showing…
Shots:Daiichi Sankyo has dosed the first patient with Enhertu in combination with Keytruda in the P-III (DESTINYLung06) trial as a 1L treatment for unresectable, LA/M HER2 overexpressing & PD-L1 (TPS<50%) non-squamous NSCLCTrial will assess Enhertu (5.4mg/kg) + Keytruda vs Keytruda + Pt-based CT + pemetrexed as the 1L treatment in the mentioned pts…
Shots:Health Canada has approved Enhertu monotx. for adult with inoperable HR+, HER2-low/ultralow MBC who have received ≥1 endocrine therapy (ET) & are ineligible for ET as the next line of therapyApproval was based on the P-III (DESTINY-Breast06) trial (N=866) assessing Enhertu (5.4mg/kg) vs CT (capecitabine/paclitaxel/nab-paclitaxel) in HR+, HER2-low (n=713) & ultralow (n=152) ptsTrial showed improved PFS…
Shots:The EC has approved Koselugo for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adults with neurofibromatosis type 1 (NF1)Approval was based on the P-III (KOMET) study assessing Koselugo (PO) vs PBO in 145 adults with NF1 & symptomatic, inoperable PNs across 13 countries incl. North America, South America, Europe, Asia &…
Shots:The EU approved Tezspire as an add-on treatment with intranasal corticosteroids for adults with severe CRSwNP unresponsive to standard therapies; regulatory review is ongoing in China, Japan, and several other countriesApproval was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by…
Shots:AstraZeneca has reported P-III (Bax24) trial data assessing baxdrostat (2mg; QD) + SoC vs PBO + SoC in 218 pts with treatment-resistant hypertension for 12wks.Trial achieved its 1EP, showing reduced 24hr. ambulatory systolic blood pressure at 12wks., with consistent efficacy across the day, incl. early morning; data to be presented at AHA’25 &…
Shots:Algen has entered into a multi-target collaboration with AstraZeneca to accelerate novel immunology target discovery, leveraging the AlgenBrain platformAs per the deal, AstraZeneca will receive exclusive rights to develop and commercialize therapies for selected targets identified through the partnership in exchange for ~555M incl. upfront, development, regulatory & commercial milestone payments AlgenBrain models disease…
Shots:The global P-III (TROPION-Breast02) trial assessed Datroway vs CT in 644 pts with previously untreated locally recurrent inoperable or metastatic TNBC, regardless of PD-L1 expression, for whom immunotherapy was not an optionTrial showed Datroway significantly improved OS & PFS vs CT in TNBC pts; data to be presented in a future meeting &…
Shots:FDA has accepted an sBLA of neoadj. Enhertu followed by paclitaxel, Herceptin & Perjeta (THP) for the treatment of adults with HER2+ (IHC 3+ or ISH+) stage 2/3 breast cancer (PDUFA: May 18, 2026)sBLA was backed by the P-III (DESTINY-Breast11) trial assessing neoadj. Enhertu alone (5.4mg/kg) ± THP vs ddAC + THP in…
Shots:The global P-III (DESTINY-Breast05) trial data assessed Enhertu (trastuzumab DXd; 5.4mg/kg) vs trastuzumab emtansine in 1,635 HER2+ primary breast cancer pts with residual invasive disease in breast or axillary lymph nodes after neoadj. therapy & a high risk of recurrenceTrial showed improved invasive disease-free survival (1EP), while OS (2EP) was immature during interim…

