Pfizer's Lorlatinib Receives EU Approval as First-Line Treatment for ALK-Positive NSCLC
Pfizer
Pharmaceutical R&D Developer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Source: PharmaCube Info
Author: info
On January 28, Pfizer announced that the European Commission had approved the new indication application for Lorviqua (lorlatinib) as a first-line monotherapy treatment for ALK-positive non-small cell lung cancer.
Lorlatinib was first approved for marketing in Japan in September 2018, and then received accelerated FDA approval in the United States in November 2018 (brand name: Lorbrena) for second-line treatment of ALK-positive metastatic NSCLC patients who had previously been treated with crizotinib and at least one other ALK inhibitor. It was subsequently approved on March 3, 2021, for first-line treatment of ALK-positive NSCLC.
In the pivotal Phase III CROWN study, lorlatinib (n=149) reduced the risk of disease progression or death by 72% (HR 0.28, P≤0.0001) compared with Xalkori (crizotinib, n=147) in previously untreated ALK+ NSCLC patients. In the key secondary endpoint of ORR, the confirmed ORR was 76% in the lorlatinib group and 58% in the crizotinib group.
Pre-specified exploratory analyses showed that the intracranial objective response rate (IC-ORR) for lorlatinib in patients with brain metastases was 82% (with CR at 71%), compared to 23% in the crizotinib group. The proportion of patients in the lorlatinib group with an intracranial duration of response (IC-DOR) lasting 1 year was 79% (n=11), while this proportion was 0% (0) in the crizotinib group.
Source: NextMed Database by PharmaCube
The CROWN study results served as the basis for lorlatinib's approval as a first-line treatment for ALK-positive NSCLC in the United States and the European Union. Based on these results, the FDA also granted full approval to the second-line indication that was initially given accelerated approval in 2018.
ALK-positive mutations account for approximately 3% to 5% of NSCLC patients. Brain metastasis is a common site of disease progression in ALK-positive NSCLC. Among ALK-positive metastatic NSCLC patients, up to 40% have brain metastases at the time of initial diagnosis. Lorlatinib is a third-generation ALK inhibitor specifically designed to inhibit the most common tumor mutations that cause resistance to current drugs and address brain metastases, and it can cross the blood-brain barrier to exert its effects.
For Pfizer, lorlatinib is what osimertinib is for AstraZeneca – both initially served as second-line therapies offering solutions for patients who developed resistance to first-generation drugs, and were subsequently promoted to first-line therapies, covering a broader patient population. According to the Nextpharma database by PharmaCube, the global sales of lorlatinib in 2020 amounted to $204 million.
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