Tags : NSCLC

Viewpoints

ViewPoints Interview: Janssen’s Kiran Patel Shares Insights on Amivantamab for

In a recent interview with PharmaShots, Kiran Patel, Vice President Clinical Development, Solid Tumor Franchise at Janssen shared his views on the regulatory submission of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. Shots: Janssen reported the BLA submission to the US FDA seeking approval […]Read More

Regulatory

Amgen Reports NDA Submission of Sotorasib to the US FDA

Shots: The NDA submission is based P-II CodeBreaK 100 study assessing Sotorasib in patients with KRAS G12C-mutated NSCLC prior treated with CT and immunotherapy The study provided durable anticancer activity with a positive benefit-risk profile The US FDA has reviewed the NDA under RTOR pilot program, which aims to explore efficient review process that ensures […]Read More

Regulatory

Takeda’s Mobocertinib (TAK-788) Receives the US FDA’s Breakthrough Therapy Designation

Shots: Shots: The BT designation is based on P-I/II study assessing the safety and efficacy of mobocertinib (160mg, qd) in patients with LA/ m NSCLC, harboring EGFR exon 20 insertion mutations, prior treated with systemic CT The P-I/II ongoing study results: mPFS (7.3mos.); ORR (43%); safety profile was manageable. The mobocertinib development program began in […]Read More