POLIVY vs ODAC: Can the Cancer Drug Score Another Indication?
The FDA’s Oncologic Drugs Advisory Committee, ODAC, are preparing to meet in early March to discuss whether to grant another indication for Roche’s potential heavyweight cancer drug, POLIVY. The decision is to be made following results of their POLARIX study. If the indication is given, Roche could stand to tap into up to $2.4 billion in peak annual sales, according to some analysts.
The antibody drug conjugate (ADC) was granted accelerated approval in 2019 in conjugation with bendamustine and rituximab (BR). It is used to treat adult patients with relapsed or refractor diffuse large B-cell lymphoma (DLBCL) who have had at least two prior therapies.
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POLIVY targets the CD79b gene, which is found on almost all B-cells, including cancerous ones. Treatment with POLIVY+BR had complete or partial remission more often than those treated with only BR, with 40% achieving complete remission with POLIVY versus 18% without.
ODAC is making the new review in light of the results from the POLARIX study, a positive confirmatory study that was required when accelerated approval was granted. The Phase III trial involved 879 patients and examined POLIVY as a DLBCL first-line treatment. After a median follow-up of three years, the study showed that the POLIVY combination treatment decreased the risk of disease or progression or death of Rituxan-chemotherapy alone by 27%.
If the indication is given, Roche could stand to tap into up to $2.4 billion in peak annual sales, according to some analysts.
Interestingly, in a statement by Roche, the company noted that overall survival data was “immature” from the POLARIX study, even though the safety profile for POLVIY plus R-CHP was comparable to R-CHOP.
The EU, Japan, and Canada have all already approved POLIVY in combination with R-CHP as DLBCL first-line treatment based on the POLARIX data. In the EMA’s review of POLIVY in March 2022, the board wrote that “the pivotal POLARIX study met its primary endpoint PFS and no meaningful differences in safety risks have been retrieved.”
ODAC is scheduled to meet on March 9th to discuss its recommendation to the FDA, whose ultimate decision is expected on April 2nd. Whilst there are no current indications as to what the FDA’s decision or ODAC’s recommendation will be, the fact that the POLARIX findings are under review is not a warning sign. The FDA has frequently convened the committee to review results from confirmatory trials, especially when drugs have previously received indications under the accelerated pathway.
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