EGFR exon 20 insertion (EGFRex20ins) mutations are uncommon mutations in non-small cell lung cancer (NSCLC) that are associated with resistance to TKI therapy. Although two new targeted therapies have ...

Two new FDA approvals for patients with lung cancer and EGFR exon 20 insertion mutations have given the subset its first targeted therapies. Recent drug approvals by the Food and Drug Administration ...

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 ...

Credit: Getty Images. A PDUFA target date of November 24, 2022 has been set for the application. The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ...

Joshua Sabari, MD, assistant professor of medicine, Medical Oncology, Perlmutter Cancer Center at NYU Langone Health, New York, New York, discusses topics involving next generation sequencing (NGS) to ...

New treatments may stall lung cancer progression in patients with EGFR exon 20 insertion mutations. After spending a warm spring day in 2022 pulling weeds and planting perennials, Renata Muller, 66, ...

Credit: FDA. According to the CRL, the application could not be approved in its present form as additional data, including a randomized controlled trial, would be required. The Food and Drug ...

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 ...

BOSTON--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced data from a poster presentation ...

July 7, 2025 – The FDA has granted quick approval to a first-of-its-kind pill for a type of lung cancer known as non-small-cell lung cancer (NSCLC). The drug, called sunvozertinib and sold as Zegfrovy ...