Pfizer scores conditional European approval in ALK-positive lung cancer with Lorviqua
pharmafile | May 8, 2019 | News story | Research and Development | Cancer, Europe, Lorviqua, NSCLC, Pfizer, lung cancer, pharma
Pfizer’s Lorviqua (lorlatinib), or Lorbrena as it is known in the US, Canada and Japan, has just been awarded conditional marketing approval from the European Commission (EC) for the treatment of anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), according to the company.
Specifically, the drug has been approved as a monotherapy for adult patients whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI.
The decision was made based on results from a Phase 1/2 study which indicated that Pfizer’s drug produced an overall response rate (ORR) of 42.9% in patients who had previously been treated with one prior ALK TKI and 39.6% in those who had received two or more.
“Over the last decade, our understanding of ALK-positive non-small cell lung cancer has advanced dramatically, leading to multiple medications for patients,” commented Dr Enriqueta Felip, of the Vall d’Hebron Institute of Oncology in Spain. “However, the common challenges associated with treating the disease, including resistance and brain metastases have created an urgent need for additional treatment options. The Lorviqua approval marks an exciting time in lung cancer innovation and I look forward to using this next-generation ALK inhibitor to treat my patients.”
As the approval awarded from the EC is conditional, Pfizer is required to submit additional efficacy data generated in post-marketing studies, including from the ongoing phase 3 trial investigating Lorviqua versus crizotinib in the first-line treatment off ALK-positive NSCLC.
“Pfizer has worked to pioneer biomarker-driven medicine for patients with ALK-positive non-small cell lung cancer and we continue to advance patient care with the approval of Lorviqua,” remarked Dr Andreas Penk, Regional President, Oncology International Developed Markets at Pfizer. “We are proud that Lorviqua is our second lung cancer medication approved in Europe within two months and our third biomarker-driven medicine for lung cancer. We look forward to making Lorviqua available for European patients with ALK-positive non-small cell lung cancer who have progressed on prior therapy with a second generation ALK medicine.”
Matt Fellows
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