Roche wins approval for new drug for heavily pretreated lymphoma

The drug, Polivy, was developed using antibody-drug conjugate technology in-licensed from Seattle Genetics. It received accelerated approval Monday for diffuse large B-cell patients relapsed or refractory after at least two prior therapies.

Text FDA Approved appearing behind ripped brown paper.

The Food and Drug Administration has approved a new drug for treating the most common form of B-cell non-Hodgkin’s lymphoma.

Swiss drugmaker Roche’s Genentech subsidiary said Monday that the FDA had given accelerated approval to Polivy (polatuzumab vedotin-piiq), combined with Genentech’s Rituxan (rituximab) and bendamustine, for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least two prior therapies.

The accelerated approval was based on results from the Phase Ib/II GO29365 study, a trial that randomized patients to receive Polivy with Rituxan and bendamustine or the latter two drugs alone. Among 40 patients receiving the triplet combination, 16 achieved a complete remission, compared with seven of the 40 who received Rituxan and bendamustine alone.

The database lists one Phase III study of Polivy in DLBCL, POLARIX. The study is randomizing 875 patients to receive Rituxan with the chemotherapy drugs cyclophosphamide, doxorubicin, vincristine and prednisone – a commonly used combination in B-cell non-Hodgkin’s lymphomas also known as R-CHOP – or the same combination with Polivy, but without vincristine.

The list price for Polivy is about $90,000, with the three-drug combination being taken every three weeks, for six cycles, a company spokesperson noted, adding that the company plans to offer patient assistance programs for those taking Polivy with Rituxan. A biosimilar of Rituxan is also FDA-approved, Celltrion’s Truxima (rituximab-abbs).

Polivy is an antibody drug conjugate, consisting of a monoclonal antibody targeting the CD79b antigen, carrying the same cytotoxic payload as another antibody-drug conjugate, Seattle Genetics’ Adcetris (brentuximab vedotin), a drug used to treat Hodgkin’s lymphoma and some forms of T-cell non-Hodgkin’s lymphoma. Genentech in-licensed Seattle Genetics’ antibody-drug conjugate technology in April 2002; Roche acquired Genentech in 2009. Seattle Genetics issued a statement Monday to announce the use of that technology in Polivy’s development.

sponsored content

A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

Patients with DLBCL who are relapsed or refractory after two or more prior therapies are considered heavily pretreated and represent a highly vulnerable population. The two approved CAR-T cell therapies, Novartis’ Kymriah (tisagenlecleucel) and Gilead Sciences’ Yescarta (axicabtagene ciloleucel), are also approved for this population. In a note to investors in March, analysts at the investment bank Cowen wrote that Polivy would be both a bridge to CAR-T therapy for patients, as well as a therapy option for patients who are refractory to or ineligible for CAR-T.

Photo: Michael_Petrov-96, Getty Images