EGFR Mutations Archives

AstraZeneca’s Tagrisso gets broader U.S. FDA nod for lung cancer

Approvals, AstraZeneca, Blockbusters, Clinical Trials, EGFR Gene, EGFR Mutations, FDA, Lung Cancer, New Indications, R&D, Therapeutics, Tumors

The U.S. Food and Drug Administration approved AstraZeneca’s top-selling treatment Tagrisso for another type of lung cancer when diagnosed at an early stage.

December 21, 2020/by Andrew Humphreys

Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab

Biologics License Application (BLA), Bispecific Antibody, Clinical Trials, EGFR Mutations, Expanded Access Program (EAP), FDA, Metastatic non-small cell lung cancer, Platinum-Based Chemotherapy, R&D

The Janssen Pharmaceutical Companies of Johnson & Johnson submitted a Biologics License Application to the U.S. Food and Drug Administration seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

December 3, 2020/by PR Newswire

AstraZeneca says Tagrisso shown to slow lung cancer spreading to brain

Analysts, Blockbusters, Brain, Business, Clinical Trials, EGFR Mutations, European Society for Medical Oncology (ESMO), Lung Cancer, Lung Tumors, R&D, Therapeutics

FRANKFURT (Reuters) – AstraZeneca’s top-selling drug Tagrisso has been shown to slow the spread of a certain type of lung cancer to the brain when diagnosed at an early stage, […]

September 19, 2020/by Andrew Humphreys

FDA Action Alert: Bristol Myers Squibb and Trevena

ALK Mutations, EGFR Mutations, European Medicines Agency, Fast Track Designation, FDA, FDA/Regulatory, Non-Small Cell Lung Cancer, Pain, Supplemental Biologics License Application, Tumors

August is a busy month on the U.S. Food and Drug Administration)’s calendar, including a target action date for Bristol Myers Squibb’s supplemental Biologics License Application for Opdivo (nivolumab) plus Yervoy (ipilimumab), dosed concomitantly with a limited course of chemotherapy, for the first-line treatment of metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

August 3, 2020/by BioSpace

Tagrisso Significantly Improves DFS in NSCLC with EGFR Mutations

Clinical Data, Clinical Trials, Disease-Free Survival (DFS), EGFR Mutations, Non-Small Cell Lung Cancer, R&D, Therapeutics

AstraZeneca released detailed data from the Phase III ADAURA clinical trial of Tagrisso (osimertinib) in early-stage epidermal growth factor receptor-mutated non-small cell lung cancer

May 29, 2020/by BioSpace

Opdivo-Yervoy Combo Snags Another FDA Approval for Lung Cancer

ALK Mutations, Approvals, Blockbusters, Chemotherapy, Double-Combination Therapies, EGFR Mutations, FDA, FDA/Regulatory, Metastatic non-small cell lung cancer, New Indications, Tumors

The FDA greenlit the combination therapy along with limited chemotherapy for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

May 27, 2020/by BioSpace

Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for JNJ-6372 for the Treatment of Non-Small Cell Lung Cancer

Breakthrough Therapy Designation, Chemotherapy, EGFR Mutations, FDA, FDA/Regulatory, Metastatic non-small cell lung cancer, Mutations

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for JNJ-61186372 (JNJ-6372) for the treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

March 10, 2020/by PR Newswire

Eli Lilly’s Cyramza Passes FDA Advisory Hurdle for NSCLC

EGFR Mutations, Lancet Oncology, Non-Small Cell Lung Cancer (NSCLC), Oncologic Drugs Advisory Committee (ODAC), Untreated Metastatic EGFR-Positive Non-Small Cell Lung Cancer (NSCLC)

Indianapolis-based Eli Lilly announced the FDA’s Oncologic Drugs Advisory Committee voted 6-5 in favor of Cyramza (ramucirumab) plus erlotinib as a potential treatment for patients with untreated metastatic EGFR-positive non-small cell lung cancer (NSCLC).

February 27, 2020/by BioSpace

FDA Grants Priority Review to Genentech’s Tecentriq Monotherapy as First-line Treatment of Certain People With Advanced Non-small Cell Lung Cancer

ALK Mutations, Biomarkers, Blockbusters, EGFR Mutations, FDA, FDA/Regulatory, Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Metastatic Squamous Non-Small Cell Lung Cancer, PD-1/PD-L1 inhibitors, Priority Review, Supplemental Biologics License Application (sBLA)

Roche Group member Genentech announced that the U.S. Food and Drug Administration accepted the company’s supplemental Biologics License Application and granted Priority Review for Tecentriq (atezolizumab) as a first-line monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer without EGFR or ALK mutations with high PD-L1 expression, as determined by PD-L1 biomarker testing.

February 19, 2020/by Business Wire

Genentech’s Tecentriq Improves OS as First-line Monotherapy in Certain People With Advanced NSCLC

Advanced Non-Small Cell Lung Cancer, Analysis, Clinical Data, Clinical Trials, EGFR Mutations, Immune Cells, Overall Survival (OS), PD-L1 protein, R&D

Genentech announced positive data from the Phase III IMpower110 study evaluating Tecentriq as a first-line monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without ALK or EGFR mutations (wild-type; WT).

September 27, 2019/by Business Wire