Pfizer’s lung cancer drug dacomitinib gets fast US review

Pfizer has grabbed a fast review for its lung cancer drug dacomitinib in the US, in an attempt to improve survival in untreated patients compared with of older drugs such as AstraZeneca’s ageing Iressa.

The FDA granted a six-month priority review for dacomitinib, with a decision due in September, for patients with locally advanced or metastatic non-small cell lung cancer with EGFR-activating mutations.

Pfizer this week decided to take a back seat in development of CAR-T cancer cell therapies, handing rights in a development tie-up with Cellectis to startup biotech Allogene.

But with a simultaneous filing for dacomitinib with the European Medicines Agency and a group of other cancer hopefuls in its pipeline, Pfizer is clearly committed to developing conventional oncology drugs.

The FDA also awarded Pfizer’s lorlatinib a priority review for lung NSCLC with ALK mutations in February.

A pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, analysts EvaluatePharma predict sales for dacomitinib of around $417 million in 2022.

This suggests Pfizer could find a niche in an indication dominated by older drugs such as Boehringer Ingelheim’s Giotrif (afatinib) and AstraZeneca’s Iressa (gefitinib).

Phase 3 results from the 1050-patient ARCHER head-to-head study as a first line therapy showed that dacomitinib could offer a survival improvement over gefitinib.

Patients in the dacomitinib arm experienced a median progression-free survival of 14.7 months, compared with 9.2 months in those treated with gefitinib.

This represented a 41% reduction in risk of disease progression or death for patient treated with Pfizer’s drug compared with gefitinib.

Side effects

The results were first revealed at last year’s American Society of Clinical Oncology (ASCO) annual meeting, and although the clear survival improvement raised eyebrows, so did the tougher side effect profile.

Study investigators noted that 66.1% of patients on dacomitinib required a dose reduction, compared with only 8% of patients on gefitinib.

The most common adverse events with dacomitinib were diarrhoea, occurring in 87% of patients, nail changes (62% of patients), rash/dermatitis (49%) and mouth sores (44%).

Final overall survival data from ARCHER 1050 is due at a medical meeting later this year.

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