Close Menu

non-small cell lung cancer

Pfizer will issue a sub-license to Abbott to develop diagnostic products to screen NSCLC tumors for the presence of rearrangements in the ALK gene.

John Castellani, CEO of the Pharmaceutical Research and Manufacturers of America, said that while the industry's commitment to using genomic strategies to advance targeted therapies is growing, the road ahead is fraught with scientific, regulatory, and reimbursement challenges.

Data presented at ASCO this week showed that NSCLC patients with EGFR mutations who received Tarceva lived twice as long without their disease progressing compared to patients who received platinum-based chemotherapy, which is currently the standard of care for first-line NSCLC therapy.

"The median progression-free survival [with crizotinib] far exceeds anything that one would expect with standard therapy in this heavily pretreated group," Nasser Hanna of Indiana University said in a presentation at ASCO reviewing interim Phase I data on the drug.

The assay will be for CO-1686, which is currently in pre-clinical development for advanced non-small cell lung cancer patients.

In preliminary studies, "researchers observed a tumor size reduction of up to 76 percent over a treatment period of up to five months" in patients who had acquired resistance to standard tyrosine kinase inhibitors.

Shortly after Pfizer's regulatory filings for the NSCLC ALK-inhibitor crizotinib in these two countries, Abbott submitted its premarket approval application with US and Japanese regulatory authorities for a FISH-based companion diagnostic test.

The test is being used in clinical trials with Pfizer's crizotinib, an anaplastic lymphoma kinase inhibitor.

EGFR has emerged as a primary area of interest in cancer research, with biopharmaceuticals like Imclone's Erbitux and Amgen's Vectibix targeting the protein, but its multiple isoforms have made it difficult to predict these drugs' effectiveness, said Yale professor Nita Maihle.

Pfizer completed submission of its NDA for the ALK-inhibiting non-small cell lung cancer drug crizotinib, and was granted a priority review from the FDA. Meantime, Abbott Molecular plans to submit "shortly" a premarket approval application for a commercial companion diagnostic that will pick out best responders to crizotinib.

Pages

23andMe has a holiday popup shop at a mall and could open additional stores, Bloomberg reports.

By studying koalas and a retrovirus that infects them, researchers may have uncovered a new sort of 'immune response' that occurs at the genomic level, Agence France Presse reports.

NPR reports that the first person in the US given a gene editing-based therapy for a genetic disorder is heading home.

In Science this week: ancient genomes reveal social inequality within individual households, new method for quantifying genetic variation in gene dosage, and more.