Lorviqua (EU), Lorbrena (US)ALK-positive, metastatic non-small cell lung cancer (NSCLC) - first-line
Lorviqua (EU), Lorbrena (US)
Licence extension / variation
Development and Regulatory status
Jan 22Approved in the EU as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor 
Dec 21Recommended for EU approval by CHMP – the extension to the existing indication is “as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor” .
Sep 21Approved in the UK for monotherapy treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor .
Mar 21FDA approves sNDA for lorlatinib as first-line treatment of ALK-positive NSCLC; EMA is also reviewing a Type II variation application for LORBRENA in the first line indication .
Dec 20The FDA also will conduct the review under Project ORBIS, an initiative introduced in 2019, which provides a framework for potential concurrent submissions and collaborative review with health authorities in Canada, Singapore, Switzerland, Australia, Brazil and the UK. Under Project ORBIS, collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries .
Dec 20US FDA has accepted for Priority Review the supplemental New Drug Application (sNDA) for lorlatinib as a first-line treatment for people with ALK-positive metastatic NSCLC. The sNDA is based on data from the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in April 2021 .
Jan 20Has orphan drug status in US .
ALK and ROS1 inhibitor
In 2016, there were 38,381 (20,560 males and 17,821 females) cases of lung cancer registered in England. Around 88% are classified as NSCLC. Approximately 3% of people with NSCLC have ALK fusion genes .
ALK-positive, metastatic non-small cell lung cancer (NSCLC) - first-line
Trial or other data
Dec 20PIII CROWN trial is reported to be still recruiting although collection of primary outcome data completed in Mar 20 .
Aug 20Interim analysis of PIII CROWN trial (n=296) finds primary endpoint of significantly improved PFS vs crizotinib is met .
Nov 19PIII trial (NCT03052608) is recruiting. Trial sites now include EU & UK sites. Collection of PFS primary outcome data is due to complete Feb 20 .
Apr 17Pfizer initiates the PIII CROWN trial to assess the efficacy of lorlatinib monotherapy, compared with crizotinib monotherapy on progression-free survival and overall survival in treatment-naive advanced ALK-positive NSCLC (NCT03052608). The randomised, open-label two-arm trial is enrolling 280 patients in Japan, and plans to expand in the US. Collection of primary outcome data is expected to complete in Feb 20 .