Regulatory Roche's Polivy approved by FDA for treating common lymphoma

Roche’s Polivy approved by FDA for treating common lymphoma


Roche’s antibody drug Polivy has been given the green light by the Food and Drug Administration (FDA) for treating individuals with diffuse large B cell lymphoma (DLBCL), a prevalent type of non-Hodgkin lymphoma, who haven’t undergone any previous therapy. Polivy is an antibody-drug conjugate that uses a protein to directly deliver chemotherapy to tumor cells, enhancing the efficacy of the treatment while minimizing side effects.

 Previously, Polivy was approved only for patients whose lymphoma had progressed following two other treatments. However, with the latest approval, the drug’s use has been significantly expanded.

DLBCL is a cancer that impacts the immune system of the body. It occurs when a type of white blood cell called B-cell grows uncontrollably and forms tumors in different parts of the body. Indications may comprise of enlarged lymph nodes, high body temperature, night sweats, decrease in weight, pain, and fatigue.

Physicians must now use Polivy in combination with another drug called R-CHP, which includes Roche’s Rituxan antibody. The decision by the FDA was grounded on data obtained from a study named POLARIX, which juxtaposed the Polivy combination with a typical R-CHOP drug therapy. The trial showed that 77% of patients who received the Polivy drug combination survived for two years without progressing, compared to 70% of those who received R-CHOP.

 The Polivy combination did not cause a higher number of adverse effects than R-CHOP. Although the Polivy combination did not show an improvement in overall survival at two years, it did offer a 27% relative risk reduction in disease progression.

Roche’s CMO (Chief Medical Officer), Levi Garraway, who is also the Global Product Development Head, said “It has been nearly 20 years since a new treatment option has become available to people newly diagnosed with diffuse large B-cell lymphoma.”

The FDA’s verdict also upgraded Polivy’s accelerated authorization for administering it after treatment failure on two other drugs into complete endorsement, which was predicated on patient improvements. In March, the FDA’s expert advisers voted 11-2 in favor of permitting Polivy’s use for early-stage treatment. However, they mentioned that the advancement in progression-free survival was limited, and there was still no proof of better overall survival. 

The advisers also observed that Polivy treatment appeared to benefit patients with high-grade lymphoma, a specific type of diffuse large B cell lymphoma, but the benefit was less clear for patients referred to as “not otherwise specified.” However, the FDA approved Polivy for use in both groups of patients.

The approval of Polivy for use in previously untreated patients with diffuse large B cell lymphoma represents a significant expansion of the drug’s use. While the improvement in progression-free survival is modest, it offers a new treatment option for patients who previously had limited options. The approval also highlights the potential of antibody-drug conjugates as a new approach to cancer treatment.

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