The U.S. Food and Drug Administration’s (FDA) staff on Tuesday raised concerns over the safety of Spectrum Pharmaceutical’s experimental cancer drug and questioned the benefits it provided over existing therapies, dragging its shares 30%.
Non-small cell lung cancer (NSCLC) was a hot topic at the recent European Society for Medical Oncology (ESMO) Congress, where several researchers presented landmark findings, many of which are considered to be firsts. Such results portend advances that could significantly improve survival for patients with this common form of cancer.
Amgen announced Tuesday morning that its initial Phase III data of its oral drug Lumakras (sotorasib) met its primary endpoint of progression-free survival in patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC).
On Monday, Novartis released results from the Phase III CANOPY-A trial, showing that its candidate canakinumab (ACZ885) failed to meet its primary efficacy endpoint in adult non-small cell lung cancer (NSCLC) patients.
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu has been approved by the U.S. Food and Drug Administration as the first HER2-directed medicine for patients with HER2-mutant metastatic NSCLC, a particularly lethal form of the disease.
The week started off with a clinical bang for Verona Pharma, Kodiak, AstraZeneca and Daiichi Sankyo as these companies posted promising data in chronic obstructive pulmonary disease (COPD), lung cancer, and macular edema respectively.
A small study of Amgen Inc.’s Lumakras drug combined with immunotherapy found it helped 29% of advanced lung cancer patients, but liver toxicity was high and further study is needed, the company said ahead of the data presentation on Sunday at the World Conference on Lung Cancer in Vienna.
One of the tenets of “personalized medicine” is that medications will be tailored to individuals based on their personalized genetics. Last year, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research approved 50 drugs. A new study found that 33, or 66% of them, were supported with genomic data.
AstraZeneca had a very busy week of international news, with progress being shown in China, positive recommendations for two drugs in Europe, and a positive clinical trial update.
AstraZeneca said on Thursday a combination of its cancer drug, Imfinzi, and chemotherapy showed promise in a late-stage trial in patients with an aggressive form of lung cancer, when given before surgery.