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The EMA’s human medicines committee also recommended approval of drugs by GSK, Moderna, STADA, Lupin Europe and Cytokinetics.
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for authorisation of seven new medicines, including two new cancer-indicated drugs.
The first is SFL Pharmaceuticals Deutschland’s Aumseqa (aumolertinib) to treat EGFR-mutated non-small cell lung cancer (NSCLC), and also Serum Life Science Europe’s Anktiva (nogapendekin alfa inbakicept) for non-muscle invasive bladder cancer (NMIBC).
For Anktiva, the EMA recommended its conditional approval in adults with carcinoma in situ, with or without papillary tumours.
The drug is given to patients whose cancer is Bacillus Calmette-Guérin (BCG)-unresponsive, an immunotherapy traditionally used in NMIBC.
[Since there] there are no authorised treatments for BCG-unresponsive NMIBC, Anktiva provides a new therapeutic option for those with the [non-muscle invasive bladder cancer (NMIBC)]”
Anktiva is administered directly into the bladder once per week for six weeks, together with BCG, then as maintenance therapy.
Current standard of care involves surgical removal of the cancer, followed by BCG treatment. However, this approach is not successful in many patients.
Considering this and that there are no authorised treatments for BCG-unresponsive NMIBC, Anktiva provides a new therapeutic option for those with the condition”
Evidence supporting approval of Anktiva in NMIBC
EMA’s recommendation for Anktiva is based on clinical data from a six-week study evaluating the immunotherapy in combination with BCG. Seventy one percent of patients had their cancer go into remission for approximately 27 months on average.
Serum Life Science Europe will submit long-term follow-up results of ongoing studies to confirm the efficacy and safety of Anktiva.
In September, the US FDA approved Inlexzo (gemcitabine intravesical system) as a novel treatment alternative for eligible BCG-unresponsive NMIBC patients.
At the time of the FDA’s decision, Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson, said: “In an area that has seen little progress for more than 40 years, Inlexzo delivers a first-of-its-kind breakthrough innovation with a bright future ahead.”
