Novartis’ Itvisma Receives the EC Approval for Spinal Muscular Atrophy

Shots: The EC has approved Novartis' Itvisma (onasemnogene abeparvovec) for the treatment of pts (≥2yrs.) living with 5q spinal muscular atrophy (SMA) harboring a confirmed bi-allelic mutation in the SMN1 gene Approval was based on the P-III (STEER) trial & supportive P-IIIb (STRENGTH) & P-I/II (STRONG) studies, where STEER showed a 2.39-point improvement in the…

ByRidhi Rastogi8 hours ago

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Roche Reports P-III (Krascendo 1) Trial Results on Divarasib for KRAS G12C-Mutant NSCLC

Shots: Roche has reported the global P-III (Krascendo 1) trial assessing divarasib monotx. (QD) vs sotorasib (QD) or adagrasib (BID) in 338 pts with previously treated KRAS G12C-mutant advanced or metastatic NSCLC The trial met its 1 & key 2EPs, with divarasib achieving improvements in both PFS & OS; data to be submitted to health…

ByRidhi Rastogi11 hours ago

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BeOne Medicines Reports P-III (MANGROVE) Trial Results for Brukinsa + Rituximab in 1L Mantle Cell Lymphoma

BeOne has reported topline P-III (MANGROVE) trial results on Brukinsa (Zanubrutinib; 160mg, PO, BID) + rituximab vs bendamustine + rituximab in 510 adults with previously untreated mantle cell lymphoma The trial met its 1EP of improved PFS as assessed by IRC, leading to a 43% reduction in the risk of progression or death; OS (2EP) was immature…

ByRidhi Rastogi1 day ago

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Novocure Receives the CE Mark for Optune Pax with CT for Pancreatic Cancer

Shots: CE Mark was based on the P-III (PANOVA-3) trial assessing Optune Pax used concomitantly with gem/nab-pac (n=285), vs CT alone (n=286) in 571 adults with locally advanced pancreatic cancer, with launch expected in Germany in coming wks. Trial improved mOS to 16.2 vs 14.2mos. in ITT, with 1yr. survival of 68.1% vs 60.2%. In…

ByRidhi Rastogi1 day ago

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AbbVie and Genmab Report P-III (EPCORE DLBCL-4) Trial Data Results on Epcoritamab + Lenalidomide for R/R DLBCL

Shots: The topline P-III (EPCORE DLBCL-4) trial results assessed epcoritamab + lenalidomide vs rituximab + gemcitabine + oxaliplatin (R-GemOx) in adults with R/R DLBCL who received ≥1L prior of therapy Trial met its 1EP, significantly improving PFS & reducing the risk of disease progression or death by 60% (US censoring) & 56% (ex-US censoring). AbbVie…

ByRidhi Rastogi2 days ago

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Roche’s Enspryng Receives the US FDA Priority Review for At-Home SC Treatment of Thyroid Eye Disease

Shots: The US FDA has accepted sBLA & granted priority review to Roche's Enspryng (satralizumab; SC) for the treatment of thyroid eye disease (TED), with a decision expected by Oct 15, 2026 sBLA was supported by P-III (SatraGO-1 & SatraGO-2) trials assessing Enspryng vs PBO in total of 258 adults with active, mod. to sev.…

ByRidhi Rastogi2 days ago

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Sanofi Reports P-III (Baby-COMET) Trial Data on Nexviazyme for Infantile-Onset Pompe Disease (IOPD)

Shots: Sanofi has reported the P-III (Baby-COMET) trial results assessing Nexviazyme (avalglucosidase alfa; 40mg/kg, Q2W, IV) in 17 treatment-naïve pediatric pts (≤12mos.) with IOPD Trial met its 1EP, with more treatment-naïve pts (≤6mos.) alive & free of invasive ventilation at 52wks., and achieved all 2EPs, including higher survival without invasive ventilation in pts at 12…

ByRidhi Rastogi2 days ago

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Zambon’s Hopledo Receives the CHMP Positive Opinion for Parkinson’s Disease and Moderate to Severe Motor Fluctuations

Shots: The CHMP has recommended Hopledo for the treatment of adults with Parkinson’s disease & mod. to sev. motor fluctuations who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatments Opinion was based on the P-III (RISE-PD) trial assessing Hopledo in pts with Parkinson’s disease & mod. to sev. motor fluctuations, which showed a…

ByRidhi Rastogi2 days ago

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Viridian Therapeutics Reports the US FDA Approval of Lumvoa (veligrotug-vvze) for Thyroid Eye Disease

Shots: The US FDA has approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED), with immediate launch planned across the US. Also, SC elegrobart BLA filing for TED on track for Q1’27 Approval was granted under FDA Priority Review & supported by the P-III THRIVE (active TED) & THRIVE-2 (chronic TED) trials, which…

ByRidhi Rastogi3 days ago

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Samsung Bioepis Reports Clinical Data on SB27 (Biosimilar, Keytruda)

Shots: Samsung Bioepis has reported the P-I & P-III trial results on SB27, a proposed biosimilar to Keytruda (pembrolizumab), which met their 1EP, with trial completion expected within 2026 The P-I trial (n=163) evaluated PK, efficacy, safety, & immunogenicity of SB27 vs EU & US-sourced Keytruda in resected stage II/IIIA NSCLC pts after adjuvant Pt-based CT,…

ByRidhi Rastogi3 days ago

Novartis’ Itvisma Receives the EC Approval for Spinal Muscular Atrophy

Roche Reports P-III (Krascendo 1) Trial Results on Divarasib for KRAS G12C-Mutant NSCLC

BeOne Medicines Reports P-III (MANGROVE) Trial Results for Brukinsa + Rituximab in 1L Mantle Cell Lymphoma

Novocure Receives the CE Mark for Optune Pax with CT for Pancreatic Cancer

AbbVie and Genmab Report P-III (EPCORE DLBCL-4) Trial Data Results on Epcoritamab + Lenalidomide for R/R DLBCL

Roche’s Enspryng Receives the US FDA Priority Review for At-Home SC Treatment of Thyroid Eye Disease

Sanofi Reports P-III (Baby-COMET) Trial Data on Nexviazyme for Infantile-Onset Pompe Disease (IOPD)

Zambon’s Hopledo Receives the CHMP Positive Opinion for Parkinson’s Disease and Moderate to Severe Motor Fluctuations

Viridian Therapeutics Reports the US FDA Approval of Lumvoa (veligrotug-vvze) for Thyroid Eye Disease

Samsung Bioepis Reports Clinical Data on SB27 (Biosimilar, Keytruda)

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