Lorlatinib approved for ALK-Positive NSCLC. The FDA expands approval of Lorlatinib for frontline treatment of ALK+ lung cancer patients.

Lorlatinib approved for ALK-Positive NSCLC by the FDA: The agency approved the supplemental new drug application to include the frontline treatment of adult patients with metastatic anaplastic lymphoma kinase-positive (ALK)-positive non-small cell lung cancer (NSCLC).

The FDA approved the supplemental new drug application (NDA) for lorlatinib (Lorbrena) to include the first-line treatment of adult patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, according to Pfizer – the agent’s manufacturer.

“For more than a decade, Pfizer has been a pioneer in delivering biomarker-driven therapies and addressing the diverse and evolving needs of people with non-small cell lung cancer,” Andy Schmeltz, global president of Pfizer Oncology, said in a company issued release. “Lorbrena has been a transformative medicine for people with ALK-positive advanced NSCLC, and this FDA approval in the first-line setting means that we can now extend hope to even more people.”

FDA Expands Approval for Frontline Treatment of ALK-Positive Patients

The expanded approval was based on data from the pivotal, randomized, open-label, parallel 2-arm phase 3 CROWN trial, designed to evaluate lorlatinib (n = 149) compared with crizotinib (Xalkori; n = 147) in previously untreated patients.

The primary end point was progression-free survival (PFS) based on blinded independent central review (BICR). Secondary end points included overall survival (OS) and tumor assessment related data by BICR, including overall response rate (ORR) and duration of response (DOR).

Treatment with lorlatinib demonstrated a 72% reduction in the risk for progression or death (HR 0.28; 95% CI, 0.19-0.41; P < .0001).

“The CROWN data have shown Lorbrena can significantly improve outcomes in the first-line treatment of ALK-positive non-small cell lung cancer, including those that present with brain metastases,” Benjamin Solomon, MD, form the Department of Medical Oncology at the Peter MacCallum Cancer Centre, said in the release. “This approval is meaningful for my patients because we now have a highly effective treatment option that can delay the progression of a typically aggressive disease.”

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