A cervical cancer treatment gets full approval in the US. The drug is also currently being evaluated in the EU

Cervical cancer, also called cervical cancer, is characterized by the appearance of atypical cells that multiply uncontrollably at the level of the cervix. Eis the fourth most common cancer in women globally, according to the World Health Organization (WHO). Romania has registered an impressive economic growth in the last decades, but nevertheless the incidence of cervical cancer is similar to that of much poorer countries, such as Venezuela, Peru, Congo or Myanmar.

The US Food and Drug Administration (FDA) has granted full approval to a drug to treat cervical cancer patients whose disease has progressed after chemotherapy, the agency announced Monday.

The treatment Tivdak (tisotumab vedotin-tftv) – an antibody-drug conjugate jointly developed by Genmab A/S and Seagen – received accelerated FDA approval for the same indication in 2021.

US pharma giant Pfizer added its treatment along with other targeted cancer therapies to its oncology portfolio after acquiring biotech company Seagen last year in a $43 billion deal.

Full approval from the health regulator was based on data from an early-stage study that enrolled 502 patients. It tested the drug against chemotherapy in cervical cancer patients.

In the study, the treatment demonstrated a 30% reduction in the risk of death compared to chemotherapy.

The European Medicines Agency (EMA) validated in February this year the marketing authorization application for this drug as a therapy for patients with metastatic or recurrent cervical cancer that has progressed during or following previous systemic therapy, according to to a press release from Pfizer and Genmab.

If the European Commission approves the granting of marketing authorization, the drug would become the first antibody-drug conjugate to receive marketing authorization in the European Union as a treatment for people with cervical cancer.

Romania has registered an impressive economic growth in the last decades, but nevertheless the incidence of cervical cancer is similar to that of much poorer countries, such as Venezuela, Peru, Congo or Myanmar.

Thus, our country registers the highest incidence and mortality rates from cervical cancer in the European Union, which are 2.7 and 3.2 times higher than the European average, according to the data submitted by the Romanian HPV Action, pilot project of the European Cancer Organization, in the context of the European Immunization Week.

If detected at an early stage, cervical cancer is curable in most cases.

Vaccination against HPV is considered the best way to prevent cervical cancer.

In Romania, anti-HPV vaccination is free for girls and boys between the ages of 11 and 18, while women between the ages of 19 and 45 benefit from anti-HPV vaccination in a 50% compensated regime.