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.
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.
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.