US regulator backs Pfizer's Vizimpro lung cancer drug

The US drug regulator has given Pfizer’s Vizimpro the green light in a group of lung cancer patients whose tumours have a certain mutation.

Vizimpro (dacomitinib) can be used as a first-line treatment for a certain type of metastatic non-small cell lung cancer (NSCLC) following the US Food and Drug Administration (FDA) approval.

The treatment is specifically for epidermal growth factor receptor (EGFR)-mutated NSCLC, in which EGFR exon 19 deletion or exon 21 L858R substitution mutations have been detected by an FDA-approved test.

The FDA made its decision based on the results of a phase 3 trial, Archer 1050, a randomised, multicentre, multinational, open-label study that involved 227 patients.

The results showed a statistically significant improvement in progression-free survival (PFS) as determined by the Independent Radiologic Central (IRC) review.

The benefits were demonstrated for patients who were treated with Vizimpro compared with AstraZeneca’s Iressa (gefitinib). Median PFS in the Vizimpro group was 14.7 months, compared with 9.2 months in the gefitinib arm.

The drug, a once-daily pill, is for patients with previously untreated unresectable, metastatic EGFR-mutated NSCLC with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy.

Andy Schmeltz, global president, Pfizer Oncology, said: “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.

“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.”

Last week, the FDA approved Qiagen’s Therascreen EGFR RGQ PCR Kit for use as a companion cancer diagnostic for Vizimpro. It identifies patients who have NSCLC with specific genetic mutations.

The test kit can now be used for three FDA-approved NSCLC therapies, alongside Boehringer Ingelheim’s Gilotrif and AstraZeneca’s Iressa.