26/02/2026 Boehringer Ingelheim's zongertinib received accelerated approval for HER2m NSCLC Izalontamab brengitecan elicited significant PFS and OS benefit in TNBC Boehringer Ingelheim's zongertinib received accelerated approval for HER2m NSCLC (Ref) The US FDA granted accelerated approval to Boehringer Ingelheim's zongertinib (kinase inhibitor) for an expanded indication for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 TKD activating mutat

10/11/2025 Boehringer Ingelheim's zongertinib received the Commissioner’s National Priority Voucher for HER2-mutant NSCLC (Ref) The US FDA awarded a Commissioner’s National Priority Voucher (CNPV) to Boehringer Ingelheim's zongertinib (HER2 TKI) for the treatment of patients with HER2-mutant NSCLC. Boehringer Ingelheim is planning a sNDA for zongertinib in the first-line treatment of patients with HER2-mutant NSCLC Previously, zongertinib received accelerated approval by the

23/09/2025 Kelun Biotech's NDA for A400/EP0031 in RET +ve NSCLC was accepted by China's NMPA (Ref) China's NMPA has accepted Sichuan Kelun-Biotech's NDA for A400/EP0031 (RET kinase inhibitor) for the treatment of adult patients with RET-fusion positive locally advanced, or metastatic NSCLC The acceptance for review was based on the positive results from the two pivotal Ph2 cohorts of the KL400-I/II-01 study for both 1L and 2L+ advanced RET-fusion positive NSCLC To note, in Ma

03/09/2025 Boehringer Ingelheim's zongertinib received the FDA Breakthrough Therapy Designation for first-line HER2-mutant advanced NSCLC (Ref) The US FDA granted the Breakthrough Therapy Designation to Boehringer Ingelheim's zongertinib (HERNEXEOS; HER2-selective tyrosine kinase inhibitor) for the first-line treatment of adult patients with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 tyrosine kinase domain activating mutations. Vicky Brown, Senior Vi

01/09/2025 Boehringer’s zongertinib received accelerated approval in China for HER2-mutant advanced NSCLC ( Ref ) China’s National...

08/08/2025 Boehringer Ingelheim's Hernexeos received accelerated approval from the US FDA for HER2-mutant advanced NSCLC (Ref) The US FDA granted accelerated approval to Boehringer Ingelheim's zongertinib (Hernexeos; kinase inhibitor) for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 TKD activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. The approval is based on data from the Phase 1b Bea

In recognition of Head and Neck Cancer Awareness Month, Oncofocus has released a concise and easy-to-read infographic that outlines the current approved therapies and noteworthy emerging therapies. Stay informed and help spread HNC awareness with this publicly accessible infographic.

Biliary tract cancers, encompassing bile duct and gallbladder malignancies, originate from the bile duct epithelium. Cholangiocarcinoma, or bile duct cancer, affects approximately 8,000 individuals annually in the United States, while gallbladder cancer is even less common, with an incidence rate of about 2 per 100,000 people. These cancers are frequently diagnosed at advanced stages, leading to poor prognoses. In the US and EU, treatment options remain scarce, although recen