European approval is expected shortly for a new targeted agent for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) activating mutations .

The new agent, dacomitinib (Vizimpro, Pfizer) received a favorable opinion at the last meeting of the European Committee for Medicinal Products for Human Use (CHMP); European approval usually follows within 67 days.

Dacomitinib is already approved for this indication in the United States.

In a press release, the CHMP stated that the benefits of dacomitinib are "its ability to increase progression-free survival (PFS) over gefitinib [Iressa, AstraZeneca]. "

This seems to refer to the results of the ARCHER 1050 trial, which has been the basis of US approval. This trial was conducted in 452 patients with unresectable metastatic NSCLC, who had received no previous treatment for metastatic disease, and in patients with recurrent disease who had not had a disease for at least 12 years. months after the end of systemic treatment.

The results showed a statistically significant improvement in PFS with the new agent: the median PFS was 14.7 months with dacomitinibcompared to 9.2 months with gefitinib (risk ratio, 0.59, P <0.0001).

However, there was no improvement in the overall response rate or overall survival.

"The results of ARCHER 1050 suggest that dacomitinib should be considered as a new first-line treatment option for patients with non-small cell lung cancer mutated by mutant EGFR." Exon 19 deletion or substitution mutations exon 21 L858R ", commented principal investigator Tony Mok, MD, professor and director of the department of clinical oncology of the Chinese University of Hong Kong, China, in a press release issued at the time of approval by the United States.

However, toxicity was higher with dacomitinib; A dose reduction was required in 66% of patients, compared with 8% for those who received gefitinib, Mok noted. present the results of the 2017 annual conference of the American Society of Clinical Oncology (ASCO).

Thus, patients should be aware of potential side effects when making therapeutic decisions, he commented.

At the time, ASCO's expert, John V. Heymach, MD, Ph.D., of the MD Anderson Cancer Center at the University of Texas, Houston, had also emphasized the toxicity of this product.

"In this study, we see a progression-free survival difference greater than 5 months," he said. "From the point of view of the doctors who treat lung cancer, it is a substantial advance and I think this really places dacomitinib at the forefront in terms of effectiveness."

However, the efficiency is at the expense of some toxicity. "About 10% of patients had grade 3 toxicity involving the skin and diarrhea, and a significant number have reduced doses, but I would like to point out that these toxicities are not a threat to life, "Heymach said. It is toxicities that doctors who treat this for a living are used to managing. This medication clearly requires close monitoring and close monitoring by experienced healthcare providers to manage toxicities. "

Overall, dacomitinib clearly appears as a potential option for patients, he added. "And as a physician, I think it would be quite appropriate to discuss different options for compromising between toxicity and efficacy," he commented at the time.

The CHMP notes that the most common side effects are diarrhea, rash, stomatitis, nail disorder, dry skin, decreased appetite, conjunctivitisweight loss, alopecia, pruritus, elevated transaminase levels and nausea.

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