Iovance Soars as Melanoma Drug Gains First International Approval
Health Canada's conditional nod for Amtagvi opens new markets for the cell therapy, following its earlier US FDA approval.
Shares of Iovance Biotherapeutics (IOVA) surged more than 12% after the company secured its first international marketing authorization for Amtagvi, a groundbreaking cell therapy for advanced melanoma. Health Canada granted the treatment conditional approval, a significant milestone that opens up a new market and revenue stream for the cancer drugmaker.
The approval allows Amtagvi, also known as lifileucel, to be used in adult patients with unresectable or metastatic melanoma whose disease has progressed after other systemic therapies. This follows the therapy's accelerated approval by the U.S. Food and Drug Administration in February 2024, which marked it as the first cellular therapy to be sanctioned for a solid tumor cancer.
"This approval in Canada is our first marketing authorization outside the US and marks a significant step forward for Iovance," said Frederick Vogt, interim chief executive officer of Iovance, in a statement. The company plans to establish its first specialized Canadian treatment center in the coming months and is pursuing approvals in other regions with high rates of melanoma.
The Canadian authorization is contingent on the results of the ongoing Phase 3 TILVANCE-301 trial, which is also intended to serve as the confirmatory study for full FDA approval in the United States. The initial approval was based on data from the Phase 2 C-144-01 clinical trial.
Data from that trial has shown promising durability. A 5-year analysis presented at the American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated an objective response rate of 31.4% and a median duration of response lasting over three years, reinforcing the therapy's long-term benefit.
Wall Street has reacted positively to the expansion. H.C. Wainwright analyst Joseph Pantginis recently reiterated a 'Buy' rating on the stock with a $20 price target, citing the Canadian announcement as a catalyst that opens up new revenue opportunities and improves the chances of securing further international approvals.