New genome editing method could swap entire genes and correct 1000 mutations at once

New technology enables the insertion of a large segment of DNA into a genome, potentially expanding gene therapy treatment ...
Healio

VIDEO: EGFR-targeted therapy, immunotherapy top discussions in non-small cell lung cancer

Of particular interest were novel therapies for EGFR exon 20 insertion mutations in non-small cell lung cancer, which ...

U.S. Food and Drug Administration Accepts New Drug Application for Zipalertinib for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 ...

Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Applicatio ...

Cullinan Therapeutics: Cash-Rich With A Major 2027 FDA Catalyst

Cullinan Therapeutics, Inc. has a cash-rich balance sheet and no financial debt while trading at a reasonable valuation. Read ...
Cancer Therapy Advisor

FDA to Review Zipalertinib for Metastatic EGFR Ex20ins NSCLC

Acceptance of the New Drug Application is based on findings from a phase 2b portion of the open-label REZILIENT1 clinical trial.
Monthly Prescribing Reference

FDA Greenlights Oral Therapy for NSCLC With EGFR Exon20 Insertion Mutations

In a primary efficacy population of 85 patients, the confirmed overall response rate was 46%. The Food and Drug Administration (FDA) has granted accelerated approval to Zegfrovy ® (sunvozertinib) for ...
Hosted on MSN

FDA accepts review of zipalertinib for rare lung cancer mutation

The FDA has accepted Cullinan Therapeutics and Taiho Pharmaceutical’s application for zipalertinib, an oral therapy for advanced non-small cell lung cancer with EGFR exon 20 insertion mutations. The ...
The American Journal of Managed Care

Current and Emerging Options for Uncommon EGFR- and Exon 20 Insertion–Mutated NSCLC

Uncommon EGFR mutations, such as exon 20 insertions, account for nearly one-third of EGFR-driven NSCLC, complicating treatment strategies due to their diversity and structural challenges. Traditional ...
Nasdaq

RYBREVANT® (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR ...

Approval is based on results from the Phase 3 PAPILLON study, which demonstrated RYBREVANT® plus chemotherapy reduced the risk of disease progression or death by 61 percent versus chemotherapy alone ...