- Bayer AG is bringing to market a new lymphoma drug that's part of an emerging class of therapies aimed at limiting cancer cell growth.
- On Thursday, the Food and Drug Administration approved the German company's Aliqopa as a third-line treatment for adults with relapsed follicular lymphoma (FL). The drug inhibits members of an enzyme family called phosphoinositide 3-kinase (PI3K), which plays a role in cell development and proliferation.
- Aliqopa's approval hinged on results from a single arm Phase 2 study that showed 59% of patients taking the drug demonstrated complete or partial tumor shrinkage. The FDA is requiring additional clinical studies to confirm those findings, however.
Cancer is the hottest therapeutic area in the industry right now. Big pharmas are shelling out billions of dollars in investment for novel therapies that will (hopefully) carve a spot for them in the growing market.
PI3K inhibitors are a relatively new kind of cancer drug. The first to market was Gilead Sciences Inc.'s Zydelig (idelalisib) back in 2014. The FDA approved the drug for a few indications, including third-line treatment for relapsed FL and small lymphocytic lymphoma.
So far, though, the drug hasn't had much success. Sales were a paltry $35 million during the second quarter, down nearly 15% from the same period in 2016, due in part to rival types of therapies and safety concerns. Gilead cited Johnson & Johnson's Imbruvica (ibrutinib) and Roche AG's Gazyva (obinutuzumab) as competitors to Zydelig in its most recent 10-Q filing with the Securities and Exchange Commission.
Imbruvica has already hit blockbuster status this year and Gazyva recently locked down approval in previously treated FL.
Bayer, however, believes its offering could have an advantage over other PI3K drugs. The company noted that Aliqopa is the only drug in its class to show "inhibitory activity predominantly against PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells."
The company also highlighted Aliqopa is the only PI3K inhibitor approved for intermittent intravenous administration — a characteristic that may actually be more of a hindrance than a selling point. Prescribers and consumers tend to prefer treatments that are quicker and easier to use, such as oral medications. Patients on Aliqopa, conversely, would have to get one-hour infusions about three times a month.
"For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments," Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research," said in a Sept. 14 statement from the agency. "Options are limited for these patients and today’s approval provides an additional choice for treatment, filling an unmet need for them."
What sets Bayer's product apart now may not be so true in the near future, though, as more PI3K inhibitors creep closer to market. Verastem Inc., for instance, disclosed earlier this month positive Phase 3 results for its drug duvelisib in relapsed chronic lymphocytic leukemia.