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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…
NEWS
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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…
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Sandoz has reported Enzeevu (Aflibercept), a biosimilar version of Eylea, is now available in Canada
Enzeevu is a single-use, PFS intravitreal injection delivering 2 mg aflibercept (2 mg/0.05 mL). It closely resembles the reference product
Enzeevu is approved for all its indications, including neovascular (wet) age-related macular degeneration (AMD), macular edema due to CRVO or BRVO, diabetic macular edema (DME), and myopic…
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The CHMP has recommended label expansion of Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone + androgen deprivation therapy (ADT) to treat adults with mHSPC & BRCA1/2 mutations
Opinion was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/ prednisolone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic…
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The CHMP has recommended Rezurock (200mg) for conditional approval in chronic GVHD pts (≥12yrs., ≥40kg), with EC’s decision expected in the coming wks.
Opinion was supported by extensive clinical data, incl. the P-II (ROCKstar) trial, which showed an improved ORR of 74% in chronic GVHD pts post–stem cell transplant & after ≥2 prior systemic…
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The CHMP has recommended Kygevvi (PO) under exceptional circumstances for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age, supported through EMA's PRIME scheme. EC decision is expected by Q2’26
Supportive evidence came from pooled data from 2 studies of Kygevvi in 39 pts with genetically confirmed TK2d & symptom…
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The CHMP has recommended EURneffy 1mg (adrenaline nasal spray) to treat allergic reactions as well as idiopathic or exercise-induced anaphylaxis in children (≥4yrs. & 15-30kg)
If granted, the approval would be valid in all 30 EEA states & will support an extension to the existing EURneffy 2 mg’s approval from Aug 2024 for emergency…

