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FDA has accepted sBLA & granted priority review to Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy (PDUFA: Q2’26)
sBLA was backed by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644 above-mentioned pts, which showed 5mos. improvement in…
NEWS
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The P-III trial evaluated CagriSema (SC; QW), a fixed-dose combination of cagrilintide & semaglutide, at two dose levels (2.4mg/2.4mg & 1mg/1mg) vs semaglutide (2.4 & 1mg), cagrilintide (2.4mg) alone, & PBO in 2,728 pts with T2D inadequately controlled with metformin ± an SGLT2 inhibitor
At 68wks., CagriSema (2.4/2.4mg) outperformed semaglutide (2.4mg), reducing HbA1c by…
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Bio-Thera and Avalon Pharma have signed commercialization and licensing agreements for BAT3306, a biosimilar version of Keytruda (Pembrolizumab)
As per the deal, Bio-Thera will oversee development, manufacturing, and supply of BAT3306, while Avalon Pharma will handle regulatory approvals and commercialization across Saudi Arabia and the MENA region
BAT3306 is a humanized monoclonal antibody and immune checkpoint inhibitor…
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Sanofi has reported P-III (LEAP2MONO) trial data assessing venglustat (QD, PO) vs enzyme replacement therapy (IV, Q2W) in 43 pts (≥12yrs.) with GD3
Trial met its 1EP, improving neurological symptoms measured by modified SARA total score & RBANS at Wk. 52, & achieved 3 of 4 key 2EPs, incl. reductions in spleen & liver…
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SanegeneBio has entered into a global licensing agreement with Genentech (Roche) to advance one of its RNAi programs, using SanegeneBio's RNAi platform
As per the deal, Genentech will receive exclusive worldwide rights to develop & commercialize the program, with SanegeneBio handling early development activities, after which Genentech will lead subsequent development & commercialization efforts …
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The CHMP has recommended Zynyz (retifanlimab) + Pt-based CT as 1L treatment of adults with metastatic or with inoperable locally recurrent SCAC
Opinion was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + carboplatin & paclitaxelvs PBO & CT in treatment-naïve SCAC pts
P-III trial showed a 37% PFS improvement (mPFS: 9.3 vs 7.4mos.); data…
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The US FDA has received a premarket approval (PMA) application of Signatera CDx for the detection of molecular residual disease (MRD) in pts with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with Tecentriq (atezolizumab)
Submission was supported by the P-III (IMvigor011) trial, which met its 1EP & showed that Signatera-guided therapy improved…
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Origami Therapeutics has entered into a global collaboration & option agreement with Ipsen to develop a small-molecule protein degrader, using Origami’s Oricision platform, for a rare inherited neurodegenerative disorder
Under the deal, Ipsen will secure an exclusive option to license the program globally after drug candidate nomination &, upon exercise, would take over worldwide…
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Alvotech has entered into supply & commercialization agreements with Sandoz for multiple biosimilar candidates across Canada, Australia, & New Zealand
In Canada, the deal includes one ophthalmology biosimilar in a prefilled intravitreal syringe, while in Australia & New Zealand, it covers 3 biosimilar candidates across immunology & gastroenterology in multiple formulations
As per the…
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Celltrion has completed the trial for Herzuma SC (CT-P6 SC), a biosimilar version of Herceptin (trastuzumab), and plans to file for marketing approval in the EU and Korea within three months
The trial, which demonstrated PK equivalence to the reference SC formulation, along with comparable safety and immunogenicity, also met its 1EP. Herzuma SC is also expected to enhance patient convenience by reducing administration…

