Cullinan Oncology and Taiho Pharmaceutical announced that Taiho was acquiring Cullinan Pearl and will co-develop and co-commercialize a non-small cell lung cancer (NSCLC) drug.
In Expected Decision, FDA Rejects Lilly’s Sintilimab in NSCLC
Alliances, Biologics License Application (BLA), Business, Checkpoint Inhibitors, Clinical Trials, Complete Response Letter, EGFR tyrosine kinase inhibitors (TKI), Eli Lilly, FDA, Hepatocellular Carcinoma, Non-Squamous Non-Small Cell Lung Cancer (NSCLC), PD-1 Inhibitors, R&D, TherapeuticsThe U.S. Food and Drug Administration rejected Eli Lilly’s Biologics License Application, issuing a Complete Response Letter for the company’s PD-1 checkpoint inhibitor sintilimab.
Lung Cancer Breakthroughs Touted at ESMO 2021
AstraZeneca, Clinical Data, Clinical Trials, Daiichi Sankyo, EGFR tyrosine kinase inhibitors (TKI), European Society for Medical Oncology (ESMO), Janssen, KRAS Mutations, Lung Cancer, Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Platinum-Based Chemotherapy, R&D, Regeneron Pharmaceuticals, Sanofi, Therapeutics, Topline DataCompanies presented very promising data for treating lung cancer at European Society of Medical Oncology (ESMO) Congress 2021.
Takeda’s non-small cell lung cancer (NSCLC) treatment Mobocertinib (TAK-788) is leading closer to regulatory approval after the U.S. Food and Drug Administration granted priority review to the New Drug Application.
AstraZeneca Plc said on April 14 that China’s health regulator expanded the use of Tagrisso, the British drugmaker’s lung cancer treatment, in patients with a type of lung cancer when diagnosed at an early stage.
ESMO News: AstraZeneca, Merck, Janssen, Amgen and More
Basal Cell Carcinoma, Blockbusters, Breast Cancer, Checkpoint Inhibitors, Clinical Data, Clinical Trial Endpoints, Clinical Trials, EGFR tyrosine kinase inhibitors (TKI), European Society for Medical Oncology (ESMO), Interim Data, MD Anderson Cancer Center, Melanoma, Metastatic Castration-Resistant Prostate Cancer (mCRPC), Metastatic non-small cell lung cancer, Non-Small Cell Lung Cancer (NSCLC), Overall Survival (OS), R&D, Renal Cell Carcinoma (RCC), Therapeutics, TumorsNumerous companies presented clinical trial data and updates at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
Researchers are having a hard time getting their hands on specimens for their work on new treatments, diagnostics, and cures.
US FDA Accepts Regulatory Submission for Tagrisso in First-Line EGFR-Mutated Non-Small Cell Lung Cancer
Breakthrough Therapy Status, Clinical Trials, CNS, EGFR tyrosine kinase inhibitors (TKI), FDA, Metastases, Mutations, New England Journal of Medicine, Non-Small Cell Lung Cancer (NSCLC), Priority Review Status, Supplemental New Drug Application (sNDA)AstraZeneca announced that the U.S. Food and Drug Administration accepted a supplemental New Drug Application for the use of Tagrisso (osimertinib) – a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central nervous system metastases – in the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR mutations.
Amgen announced that the U.S. FDA approved the supplemental Biologics License Application for Vectibix (panitumumab) for patients with wild-type RAS metastatic colorectal cancer.
A targeted drug being developed by Pfizer Inc. held advanced lung cancer in check longer than AstraZeneca’s Iressa in newly diagnosed patients, but with a higher rate of side effects, according to data.