EMA Recommends Granting a Conditional Marketing Authorisation for Polatuzumab Vedotin

It is intended for the treatment of relapsed/refractory DLBCL in combination with bendamustine and rituximab

On 14 November 2019, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product polatuzumab vedotin (Polivy), intended for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in combination with bendamustine and rituximab.

The applicant for this medicinal product is Roche Registration GmbH.

Polivy will be available as a 140 mg powder for concentrate for solution for infusion. The active substance of Polivy is polatuzumab vedotin (ATC code: L01XC37), a CD79b targeted antibody-drug conjugate that preferentially delivers a potent anti-mitotic agent (monomethyl auristatin E, or MMAE) to B cells, which results in the killing of malignant B-cells.

The benefits with Polivy in combination with bendamustine and rituximab are its ability to elicit higher rates of complete responses as compared to bendamustine – rituximab alone. The most common side effects are infections, neutropenia, thrombocytopenia, anaemia, leukopenia, lymphopenia, neuropathy, dizziness, cough, gastrointestinal disorders, fatigue, pyrexia, asthenia, chills and infusion-related reactions.

The full indication is: Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory DLBCL who are not candidates for haematopoietic stem cell transplant.

It is proposed that Polivy must only be administered under the supervision of a healthcare professional experienced in the diagnosis and treatment of cancer patients.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is likely to provide comprehensive clinical data at a later stage.

This product was designated as orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained.