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U.S. FDA Approves Vizimpro® (Dacomitinib) For The First-Line Treatment Of Patients With EGFR-Mutated Metastatic Non-Small Cell Lung Cancer

(Pfizer) Sept 27, 2018 - Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved VIZIMPRO® [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. “Improving outcomes for patients is the central focus of why we develop and deliver new medicines. VIZIMPRO is yet another example of Pfizer’s commitment to providing more options in lung cancer where there is great unmet need,” said Andy Schmeltz, Global President, Pfizer Oncology. “With today’s approval, Pfizer has medicines that target three unique lung cancer biomarkers, marking real progress for patients which has been achieved through a diverse and persistent drug development approach.”

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H. Jack West, MD (Posted: September 28, 2018)

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Dacomitinib clearly has activity for EGFR mutation-positive NSCLC, but I suspect this approval will have very little impact in the already crowded first line landscape. Dacomitinib is clearly superior to gefitinib in both PFS and even OS based on the ARCHER-1050 trial. Osimertinib, however, is now the emerging first line standard of care and is likely to remain so for several reasons:
1) Dacomitinib toxicity is quite challenging, with 66.5% of patients assigned to daco on ARCHER-1050 requiring dose reduction and very high rates of misery-inducing side effects. Osimertinib is generally very well tolerated.
2) ARCHER-1050 excluded patients with known brain metastases, while osimertinib has consistently impressive CNS activity, with a CNS RR of 91% in the FLAURA trial among patients who started with baseline measurable brain mets. CNS control for existing or potential future brain mets is an increasingly significant factor when one option is clearly superior in this regard.
3) Though Pfizer may argue that starting with daco preserves the potential for osimertinib later, only a very small minority of the patients on ARCHER-1050 actually got osimertinib, so we should not presume this will be trivially easy to accomplish for the majority of patients. PFS for first line osi vs. daco is more than 3 months longer with osi.
4) At least among lung cancer experts, but I believe among oncologists in general, Pfizer has had very little presence, while AZ has been heavily marketing and running educational programs. This is a minor factor next to the data, but it is just one more obstacle for Pfizer to overcome. It has shown no interest in developing relationships with oncologists or in cultivating a sense of corporate citizenship by sponsoring educational activities or supporting other valuable programs in the oncology community over many years.

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