FDA Advisory Committee Decisions Impact Genentech and Johnson & Johnson Drug Expansions

Genentech's Columvi Faces Setback in Expansion Bid

The U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) has dealt a significant blow to Genentech's efforts to expand the use of its bispecific antibody, Columvi. In an 8-1 vote, the committee rejected the proposal to combine Columvi with gemcitabine and oxaliplatin for transplant-ineligible patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).

The primary concern raised by the ODAC centered on the applicability of Genentech's Phase III STARGLO study to the broader U.S. population. Notably, half of the study's intention-to-treat population comprised Asian patients, with only 25 patients enrolled from North America. This demographic imbalance prompted skepticism about the data's relevance to U.S. patients.

Ravi Madan, head of Prostate Cancer Clinical Research at the National Cancer Institute, emphasized the need for drug sponsors to make "deliberate decisions" to ensure their data "does apply to the U.S. population," especially given the global nature of oncology therapeutic development.

Columvi, which targets CD20 and CD3 proteins, received FDA approval in June 2023 for R/R DLBCL patients who had undergone at least two prior lines of systemic therapy. Genentech, a Roche subsidiary, sought to broaden its use to address what it described as an "urgent need for effective, immediately available therapies" in transplant-ineligible R/R DLBCL patients.

Johnson & Johnson's Darzalex Faspro Gains Advisory Committee Support

In contrast to Genentech's setback, Johnson & Johnson received positive news from the same ODAC meeting. The committee voted 6-2 in favor of expanding the use of Darzalex Faspro, an anti-CD38 antibody, to adult patients with high-risk smoldering multiple myeloma.

The FDA's experts found Darzalex Faspro's benefit-risk profile as a single-agent therapy to be favorable in this patient population. This recommendation paves the way for potential approval in this new indication, adding to Darzalex Faspro's existing approvals in multiple myeloma.

Implications for the Pharmaceutical Industry

These contrasting outcomes highlight the complexities and challenges in expanding drug indications, particularly in oncology. The FDA's focus on ensuring the applicability of clinical trial data to the U.S. population underscores the importance of diverse and representative patient enrollment in global studies.

For Genentech, the ODAC's decision represents a significant hurdle in their strategy to broaden Columvi's market reach. The company will likely need to reassess its approach and potentially conduct additional studies with a more U.S.-centric patient population to address the committee's concerns.

Johnson & Johnson, on the other hand, stands to benefit from the positive ODAC recommendation for Darzalex Faspro. If approved by the FDA, this expansion could provide a new treatment option for patients with high-risk smoldering multiple myeloma, potentially capturing a larger share of the multiple myeloma market.