2019-04-16| Trials & Approvals

Vizimpro bags EU approval for NSCLC treatment

by Rajaneesh K. Gopinath
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By Rajaneesh K Gopinath, Ph.D.

Pfizer’s kinase inhibitor, Vizimpro (dacomitinib) that was approved by the USFDA last September, received the marketing authorization from the European Commission for treating a rare form of lung cancer that exhibits poor survival rate.

Non-small cell lung cancer (NSCLC) constitutes 85% of all lung cancers and they are difficult to treat with the chemotherapy options currently available. A number of driver mutations define the subset of NSCLC and the most prominent one is on the Epidermal Growth Factor Receptor (EGFR). Around 10–35% of NSCLC patients have drug sensitizing mutations on EGFR. On April 3rd, Pfizer announced that their tyrosine Kinase inhibitor, Vizimpro was approved in EU as a monotherapy for the first line treatment of patients suffering from locally advanced or metastatic NSCLC harboring either of the two EGFR mutations, the exon 19 deletion or exon 21 L858R substitution. The drug is previously approved in the United States, Japan and Canada for NSCLC treatment in adult patients with EGFR mutations.

ARCHER 1050 Phase 3 clinical trial
The approval is an outcome of a successful phase 3 clinical trial called ARCHER 1050, that was conducted jointly by Pfizer and SFJ Pharmaceuticals following their collaborative agreement in 2012. ARCHER 1050 is a randomized, multicenter, multinational, open-label, Phase 3 study conducted in 452 patients with unresectable, metastatic or recurrent NSCLC with the above-mentioned EGFR mutations. In this study, dacomitinib 45 mg (n=227) was pitted against AstraZeneca’s lung cancer drug gefitinib 250 mg (n=225). A statistically significant improvement was demonstrated in the progression-free survival (PFS), which was the primary endpoint of the study (HR = 0.59 [95% CI: 0.47, 0.74], P<.0001).

“Lung cancer remains the leading cause of cancer-related death worldwide and despite advances in biomarker-driven therapies, overcoming resistance continues to be crucial in treating EGFR-mutated non-small cell lung cancer,” said Andreas Penk, M.D., regional president, Oncology International Developed Markets at Pfizer. “The marketing authorization of VIZIMPRO, which has shown a more than five-month improvement in progression-free survival over an existing therapy in a Phase 3 clinical trial, provides a new option for patients with EGFR-mutated non-small cell lung cancer and reinforces Pfizer’s ongoing commitment to addressing the remaining needs of the thousands of EU patients with this disease.” he added.



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