FDA Advisory Committee Delivers Setbacks to Pfizer and Roche, Offers Mixed Results for Other Pharma Companies

In a series of high-profile decisions, the FDA's Oncologic Drugs Advisory Committee (ODAC) has dealt significant blows to expansion efforts by pharmaceutical giants Pfizer and Roche, while delivering mixed results for other industry players. The committee's recent two-day meeting has set the stage for potential shifts in treatment landscapes across multiple cancer indications.

Pfizer's Talzenna Faces Unanimous Rejection for Broader Prostate Cancer Use

In a stunning rebuke, ODAC voted 8-0 against recommending Pfizer's PARP inhibitor Talzenna (talazoparib) for use in a broader prostate cancer population. The committee found that Pfizer's data lacked the precision needed to establish efficacy in patients with metastatic castration-resistant prostate cancer (mCRPC) who do not carry homologous recombination repair (HRR) mutations.

Pfizer had sought to expand Talzenna's label based on results from the Phase III TALAPRO-2 trial, which showed improved overall survival when Talzenna was combined with Xtandi (enzalutamide) in mCRPC patients, regardless of HRR mutation status. However, FDA reviewers and committee members expressed concerns about the study design and statistical analysis.

"Precision oncology demands precision trials," said Neil Vasan, assistant professor at Columbia University Medical Center, explaining his negative vote. "The study was not powered to test the efficacy in the patients without HRR mutations."

Richard Pazdur, M.D., the FDA's oncology chief, criticized Pfizer's approach, stating, "In this situation where you're talking about a huge number of patients, you don't need proof—you need robust proof."

Roche and UroGen Face Setbacks, While J&J Sees Potential Breakthrough

The ODAC meeting also delivered disappointing news for Roche, voting 8-1 against the applicability of results from its late-stage Starglo trial to U.S. patients. The study examined the combination of Columvi (glofitamab) and GemOx chemotherapy in diffuse large B-cell lymphoma (DLBCL) patients ineligible for stem cell transplant.

UroGen Pharma received a split decision, with a narrow 4-5 vote against its intravesical solution of Jelmyto (mitomycin) for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Despite the setback, UroGen's CEO Liz Barrett remained optimistic, noting, "We continue to believe our clinical data support UGN-102 for the treatment of recurrent LG-IR-NMIBC, a disease with no FDA-approved therapies."

In a rare positive outcome from the meeting, Johnson & Johnson's Darzalex Faspro (daratumumab and hyaluronidase-fihj) received a favorable 6-2 vote for its use in high-risk smoldering multiple myeloma. If approved, Darzalex would become the first medication specifically approved to treat this precursor condition to active myeloma.