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.

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.

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, the British drugmaker said on Saturday. A study with patients diagnosed early enough for the lung tumor to be surgically removed, and who have a […]

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.

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

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.

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.

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).

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.

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).