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Astellas
NEWS

Astellas Reports the Health Canada’s Approval of Vyloy (Zolbetuximab) Plus Chemotherapy for Advanced G/GEJ Cancer

Shots: The Health Canada has approved Vyloy + fluoropyrimidine & Pt-based CT as a 1L treatment of locally advanced unresectable or metastatic CLDN 18.2+/HER2-ve G/GEJ adenocarcinoma, with further submissions under review. In addition, Canada’s Drug Agency (CDA-AMC) recommended reimbursement of Vyloy with conditions Approval was based on the P-III (SPOTLIGHT: n= 565 & GLOW:…
January 10, 2025

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J&J
NEWS

Johnson & Johnson Reports the US FDA’s BLA Acceptance of Nipocalimab with Priority Review for Generalized Myasthenia Gravis (gMG)

Shots: The US FDA has accepted & granted priority review to the BLA of nipocalimab for treating patients with antibody positive (anti-AChR, anti-MuSK, anti-LRP4) gMG, based on P-III (Vivacity-MG3) trial. MAA in this indication has been filed with the EMA on Sep 11, 2024 The P-III study assessed safety & efficacy of nipocalimab +…
January 10, 2025

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GSK
NEWS

GSK’s GSK’227 Secures the US FDA’s Breakthrough Therapy Designation for Treating Late-Line R/R Osteosarcoma

Shots: The US FDA has granted BTD to GSK5764227 (GSK’227) for treating r/r osteosarcoma in patients with disease progression on at least 2 prior lines of therapy Designation was supported by P-II (ARTEMIS-002) trial (carried out by Hansoh Pharma) assessing the safety & efficacy of GSK’227 to treat patients (n=60; 42 had osteosarcoma) with…
January 7, 2025

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Amgen
NEWS

Amgen’s Imdylltra (Tarlatamab) Secures the MHRA’s Conditional Marketing Authorization as a 3L Treatment of ES-SCLC

Shots: The MHRA has granted conditional marketing authorization to Imdylltra for treating adults with ES-SCLC, whose disease progressed post prior 2 lines of treatment. Further evaluation is underway This authorization was supported by P-II (DeLLphi-301) study assessing Imdylltra (10mg, Q2W) in ES-SCLC patients (N=99). It showed ORR of 41% & mDoR of 9.7mos. …
January 6, 2025

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Astellas
NEWS

Astellas’ Vyloy (Zolbetuximab) Secures the NMPA’s Approval as a 1L Treatment of Advanced G/GEJ Adenocarcinoma

Shots: The NMPA has granted approval to Vyloy + fluoropyrimidine & Pt-based CT as a 1L treatment of locally advanced unresectable or metastatic HER2-, CLDN18.2+ G/GEJ adenocarcinoma Approval was supported by P-III (GLOW: n=145 & SPOTLIGHT: n=36) studies assessing Vyloy + CAPOX & mFOLFOX6, respectively, vs PBO among Chinese patients with this indication …
January 6, 2025

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GSK
NEWS

GSK’s Nucala (Mepolizumab) Secures the NMPA’s Approval for Treating Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Shots: The NMPA has approved Nucala as an add-on therapy with intranasal corticosteroids in CRSwNP adults with inadequately controlled disease. It is approved for patients (≥12yrs.) as an add-on treatment of severe eosinophilic asthma & for adults having eosinophilic granulomatosis with polyangiitis Approval was based on 2 P-III studies: MERIT assessing Nucala vs PBO…
January 3, 2025

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Innovent
NEWS

Innovent Reports the NMPA’s Approval of Dovbleron (Taletrectinib Adipate Capsule) for Treating ROS1-Positive NSCLC

Shots: The NMPA has approved another NDA of Dovbleron (ROS1 tyrosine kinase inhibitor) for treating locally advanced or metastatic ROS1+ NSCLC. It was approved for those with ROS1+ NSCLC previously treated with ROS1 TKIs in Dec 2024 The approval was supported by pivotal P-II (TRUST-I) study assessing safety, tolerability and efficacy of Dovbleron to…
January 3, 2025

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Hutchmed
NEWS

HUTCHMED Reports the NMPA’s NDA Acceptance of Orpathys Plus Tagrisso with Priority Review for EGFR-Mutated NSCLC with MET Amplification

Shots: The NMPA has accepted and granted priority review to NDA of Orpathys (savolitinib) + Tagrisso (osimertinib) for treating locally advanced or metastatic EGFR-mutated NSCLC with MET amplification in patients progressed on 1L EGFR inhibitor therapy. HUTCHMED will receive milestone from AstraZeneca Submission was based on P-III (SACHI) study assessing the safety & efficacy…
January 2, 2025

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