Latest news and insights on the pharmaceutical industry | Indian Pharma Post

Results For "epidermal-growth-factor-receptor"

33 News Found

CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings
Diagnostic Center | May 01, 2025

CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings

Phesgo label expansion delivers on patients’ preference for at-home administration and is an important step in freeing up cancer care capacity in clinical settings


CuraTeQ Biologics receives positive opinion for biosimilar Dazublys from EMA
Drug Approval | April 28, 2025

CuraTeQ Biologics receives positive opinion for biosimilar Dazublys from EMA

Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein


AstraZeneca’s Imfinzi-based perioperative regimen approved in EU for resectable non-small cell lung cancer
Drug Approval | April 04, 2025

AstraZeneca’s Imfinzi-based perioperative regimen approved in EU for resectable non-small cell lung cancer

Approval based on AEGEAN Phase III trial results which showed a 32% reduction in the risk of recurrence, progression or death vs. neoadjuvant chemotherapy alone


Pfizer announces Phase 3 PATINA study in patients with HR+, HER2+ metastatic breast cancer
News | December 13, 2024

Pfizer announces Phase 3 PATINA study in patients with HR+, HER2+ metastatic breast cancer

IBRANCE is the first CDK4/6 inhibitor to show benefit in a large Phase 3 trial in first-line HR+, HER2+ metastatic breast cancer, in combination with anti-HER2 and endocrine therapy


Arvinas and Pfizer presents phase 1b data from the TACTIVE-U sub-study of Vepdegestrant in combination with Abemaciclib at 2024 San Antonio Breast Cancer Symposium
Diagnostic Center | December 11, 2024

Arvinas and Pfizer presents phase 1b data from the TACTIVE-U sub-study of Vepdegestrant in combination with Abemaciclib at 2024 San Antonio Breast Cancer Symposium

Vepdegestrant in combination with abemaciclib demonstrated encouraging clinical activity (clinical benefit rate


Tagrisso recommended for approval in the EU for unresectable EGFR-mutated lung cancer
Drug Approval | November 19, 2024

Tagrisso recommended for approval in the EU for unresectable EGFR-mutated lung cancer

Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years


FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation
Drug Approval | October 11, 2024

FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation

Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting


AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin
Drug Approval | September 28, 2024

AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin

Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression


Imfinzi approved in the US for the treatment of resectable non-small cell lung cancer
Drug Approval | August 17, 2024

Imfinzi approved in the US for the treatment of resectable non-small cell lung cancer

Based on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone


Tagrisso with the addition of chemotherapy approved in Japan as new 1st-line treatment for patients with EGFR-mutated advanced lung cancer
Drug Approval | June 26, 2024

Tagrisso with the addition of chemotherapy approved in Japan as new 1st-line treatment for patients with EGFR-mutated advanced lung cancer

Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care