FDA green lights Pfizer’s Lorbrena for aggressive lung cancer

The US Food and Drug Administration (FDA) approved the treatment for patients with a specific gene mutation who had been previously treated for an aggressive form of non-small cell lung cancer (NSCLC).

Lorbrena can be used to treat advanced NSCLC in patients who have a mutation of the anaplastic lymphoma kinase (ALK) gene and who have relapsed after being treated with ALK TKI inhibitors.

Pfizer’s Xalkori (crizotinib) was introduced as the first TKI for the treatment of ALK-positive metastatic NSCLC in 2011, giving patients treatment options other than chemotherapy.

Since then, Novartis’ Zykadia (ceritinib) and Roche’s Alecensa (alectinib) have been approved, either in untreated ALK-positive lung cancer, or in the second line indication.

Approval of Lorbrena was given the go-ahead under accelerated approval based on tumour response rate and duration of response.

A phase 1/2 trial showed an overall response rate (ORR) of 48%. More than half (57%) had previous treatment with more than one ALK tyrosine kinase inhibitor (TKI).

Andy Schmeltz, global president, Pfizer Oncology, said: "Over the years, Pfizer has transformed research, management and treatment for patients with ALK-positive non-small cell lung cancer. Building upon our extensive understanding of tumour complexity and treatment resistance, Lorbrena was discovered by Pfizer scientists and developed specifically to inhibit tumour mutations that may drive resistance to other ALK tyrosine kinase inhibitors.

"We believe that Lorbrena will benefit patients with ALK-positive metastatic non-small cell lung cancer that have progressed on prior therapy and continue to deliver on our commitment to addressing unmet needs of cancer patients."

Many ALK-positive metastatic NSCLC patients respond to initial TKI therapy, but relapse. Options for patients have been limited, and Lorbrena gives them another avenue for oral treatment.

Alice Shaw, professor of medicine at Harvard Medical School, and director of the Center for Thoracic Cancers at Massachusetts General Hospital, said: "The last decade has witnessed dramatic improvements in the treatment of metastatic ALK-positive non-small cell lung cancer due to earlier generation ALK biomarker-driven therapies.

"Yet almost all patients still relapse due to drug resistance, with a large proportion of patients developing new or worsening brain metastases. In a clinical study, which included patients with or without brain metastases, Lorbrena demonstrated clinical activity in patients with metastatic ALK-positive non-small cell lung cancer who had failed other ALK biomarker-driven therapies."

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