Genmab, Pfizer’s tisotumab vedotin takes a leap towards EU approval for cervical cancer

In a significant development for cervical cancer treatment, Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE: PFE) have announced the European Medicines Agency’s (EMA) validation for review of the marketing authorization application (MAA) for tisotumab vedotin. This antibody-drug conjugate (ADC), developed to treat adult patients with recurrent or metastatic cervical cancer who have progressed on or after systemic therapy, could become the first of its kind to receive marketing authorization in the European Union (EU).

The MAA submission is bolstered by compelling data from the global, randomized, Phase 3 innovaTV 301 trial (NCT04697628), where tisotumab vedotin showcased superior overall survival (OS), progression-free survival (PFS), and a confirmed objective response rate (ORR) in patients with previously treated recurrent or metastatic cervical cancer compared to standard chemotherapy. Additionally, the application includes data from the innovaTV 204 pivotal Phase 2 single-arm clinical trial, which evaluated TIVDAK (tisotumab vedotin) as a monotherapy in this patient population. Notably, the safety profile of tisotumab vedotin in the innovaTV 301 trial was consistent with previously documented safety information.

Genmab CEO, Jan van de Winkel, Ph.D., emphasized the significance of this milestone, highlighting the company’s commitment to addressing the therapeutic needs of patients suffering from recurring or metastatic cervical cancer. Pfizer’s Chief Development Officer for Oncology, Roger Dansey, M.D., also reflected on the progress, underscoring the collaborative efforts with regulatory authorities to potentially deliver this innovative therapeutic option to those battling the debilitating disease.

Cervical cancer remains a critical health challenge worldwide, with a pressing need for more effective treatment options. The potential approval of tisotumab vedotin in the EU represents a hopeful advancement for women diagnosed with this devastating condition, offering a new therapeutic avenue that may improve outcomes for those who have limited options after first-line therapy.

The EMA’s review of tisotumab vedotin signifies a pivotal advancement in the treatment landscape for recurrent or metastatic cervical cancer. By targeting the disease with a novel mechanism of action, this therapy could fill a significant unmet need, offering hope to patients who have exhausted other treatments. This development is a testament to the ongoing innovation in oncology, aiming to provide patients with more effective and targeted therapeutic options.