(Alliance News) - Pfizer Inc on Tuesday said that the US Food & Drug Administration has agreed to review its licence application to get full approval for Tivdak in patients with recurrent or metastatic cervical cancer.

Pfizer is a New York City-based pharmaceutical firm, while Tivdak - or tisotumab vedotin-tftv - is an antibody-drug conjugate indicated for patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.

The US FDA has accepted its supplemental biologics licence application seeking to convert the accelerated approval of Tivdak to full approval for the treatment of cancer patients.

The application has been granted Priority Review with a Prescription Drug User Fee Act goal date of May 9, 2024.

The therapy was previously granted accelerated approval in the US back in September 2021, based on tumour response and durability of response from the innovaTV 204 pivotal Phase 2 single-arm clinical trial.

Of the application for full approval, Roger Dansey, Pfizer's chief development officer of oncology, said: "The Phase 3 innovaTV 301 trial demonstrated a favourable benefit/risk profile, including improvement in overall survival, and adds to the overall data supporting Tivdak as a treatment option for people with recurrent and metastatic cervical cancer who have limited treatment options."

Dansey added: "The FDA acceptance of our sBLA for review is important progress toward continuing to offer an option that can extend the lives of more adults with cervical cancer."

Tivdak comes with a boxed warning for ocular toxicity, as well as several other warnings and precautions for peripheral neuropathy, haemorrhage, pneumonitis, severe cutaneous adverse reactions, and embryo-fetal toxicity.

Ocular adverse reactions occurred in 60% of patients with cervical cancer treated with Tivdak across clinical trials. Peripheral neuropathy - which is a type of nerve damage - occurred in 42% of cervical patients treated, while haemorrhage occurred in 62% of cervical cancer patients treated.

Shares in Pfizer were up 0.4% at USD29.70 in the New York pre-market on Tuesday morning.

By Holly Beveridge, Alliance News reporter

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