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 ...
MedCity News

With FDA Nod in Lung Cancer, Dizal Now Aims to Best a J&J Drug and Succeed Where Takeda Fell Short

One of the more competitive targets in lung cancer is a certain mutation that has eluded many available targeted therapies. A drug developed by Dizal Pharmaceutical has received FDA approval for ...
clinicaladvisor.com

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 ...
MedPage Today

FDA OKs Amivantamab as First-Line Lung Cancer Treatment

The FDA approved amivantamab (Rybrevant) plus combination chemotherapy for the first-line treatment of non-small cell lung cancer (NSCLC) in patients whose tumors harbor EGFR exon 20 insertion ...
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

ArriVent BioPharma Reports Promising Clinical Data for Firmonertinib and Highlights Strategic Developments in Cancer Treatment

ArriVent BioPharma, Inc. has announced promising findings from its clinical studies involving firmonertinib, an EGFR inhibitor promising strong anti-tumor activity against non-small cell lung cancer ...
Monthly Prescribing Reference

Rybrevant Combo Approved as First-Line Tx for NSCLC With EGFR Exon 20 Insertion Mutations

Results showed a statistically significant improvement in progression free survival in patients treated with amivantamab with carboplatin + pemetrexed compared with those who received carboplatin + ...
KXAN

Dizal Submits New Drug Application to the U.S. FDA for Sunvozertinib in Treating Relapsed or Refractory Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

The submission is supported by data from the pivotal WU-KONG1 Part B study, which featured in an oral session at the 2024 ASCO Annual Meeting Sunvozertinib is the world's first and only oral drug ...