Skip to content Skip to footer
Subscribe Now
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

Read more

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

Read more

Exclusive_Moitreyee Chatterjee-Kishore_2024
EXCLUSIVE

Decoding Approval: Moitreyee Chatterjee-Kishore from Astellas in an Exclusive Conversation with PharmaShots

Shots: Recently EC granted Marketing Authorization to Astellas’ VYLOY (zolbetuximab) in combination with chemotherapy for the treatment of patients with advanced gastric and GEJ cancers Zolbetuximab, a monoclonal antibody designed to target gastric tumor cells that express CLDN18.2 biomarker Today, at PharmaShots we have Dr. Moitreyee Chatterjee-Kishore the Head of Development, Immuno-Oncology and Cancer Cell…
September 26, 2024

Read more

Astellas
News

Astellas Reports the CHMP’s Positive Opinion of Zolbetuximab to Treat Gastric and Gastroesophageal Junction Cancer 

  Shots:   The CHMP has granted positive opinion to zolbetuximab + CT, with the decision anticipated in Oct 2024 & applicable across the whole EU plus Iceland, Liechtenstein & Norway. Other worldwide regulatory applications are under review Opinion was supported by 2 P-III studies assessing zolbetuximab plus mFOLFOX6 [SPOTLIGHT (n=565)] & CAPOX [GLOW (n=507)] vs PBO…
July 29, 2024

Read more

VIEWPOINTS_Moitreyee Chatterjee-Kishore1_Kohei Shitara2_2024
VIEWPOINTS

Unlocking Approval: Moitreyee Chatterjee-Kishore from Astellas & Kohei Shitara in Conversation with PharmaShots

Shots: East Asia and East Europe report significant incidences of Gastric Cancer. In 2022, Japan registered around 44,000 mortalities due to Gastric Cancer VYLOY, an anti-claudin 18.2 (CLDN18.2) monoclonal antibody, received Japan’s approval in combination with chemotherapy for patients with HER2 -ve, CLDN18.2+ve, unresectable, advanced, or recurrent gastric cancer Today, at PharmaShots we have Moitreyee…
June 24, 2024

Read more

Sign Up to Our Newsletter

Be the first to know the latest updates

[mc4wp_form id="13387" element_id="style-1"]