Tags : Mutation

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

Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for

Shots: The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in patients with advanced NSCLC with KRAS G12C mutation whose cancer had progressed despite prior treatment with CT and/or immunotherapy The company is currently recruiting in a P-III study (CodeBreaK 200) assessing sotorasib vs docetaxel in patients with KRAS G12C-mutated NSCLC. Amgen […]Read More

Regulatory

Novartis’ Piqray (alpelisib) + Fulvestrant Receive FDA’s Approval for Patients

Shots: The approval is based on P-III SOLAR-1 study result assessing Piqray (alpelisib) + Fulvestrant vs Fulvestrant in 572 postmenopausal women/men in ratio (1:1) with PIK3CA-mutated HR+/HER2- advanced/m-breast cancer, following aromatase inhibitor prior treated with/without CDK4/6 inhibitor The P-III SOLAR-1 study result: mPFS (11.0 mos. vs 5.7mos.); ORR (35.7% vs 16.2%). Piqray & its associated […]Read More

Regulatory

Vertex‘s Orkambi (lumacaftor/ivacaftor) Receives Health Canada Approval for Cystic Fibrosis

Shots: The approval is based on P-III study results assessing Orkambi in 60 patients with CF, who have two copies of the F508del CFTR mutation aged 6 to 11 years for 24 wks. The P-III study demonstrated in reduction of sweat chloride by 31.7 mmol/L and was well-tolerated, Presented at European Cystic Fibrosis Society Conference in June 2018 Orkambi is a combination […]Read More