Pfizer Advances Oncology Pipeline with BRAFTOVI Trial Success and HYMPAVZI Expansion

Pfizer reported that its BRAFTOVI combination therapy produced significant progression free survival benefits in previously untreated metastatic colorectal cancer patients with the BRAF V600E mutation in a Phase 3 trial. The BREAKWATER trial evaluated the BRAFTOVI plus cetuximab and FOLFIRI regimen in this patient population.

The FDA granted Priority Review for a HYMPAVZI filing that seeks to expand its use to hemophilia A or B patients, including pediatric populations. The potential pediatric hemophilia expansion for HYMPAVZI includes once weekly administration.

If the data package satisfies regulators, Pfizer could move from an accelerated approval setting toward a broader first line role in BRAF V600E-mutant metastatic colorectal cancer, which is a smaller but higher need subgroup of patients. The positive progression free survival data strengthens Pfizer's push into targeted colorectal cancer, a segment where players like Merck, Bristol Myers Squibb and Roche are also active.

Pfizer is one of the largest and most successful drugmakers in oncology with an established presence in breast, genitourinary, thoracic, gastrointestinal cancer and blood cancers. It boasts a strong portfolio of approved cancer medicines as well as a robust pipeline of cancer candidates with a focus on multiple modalities, including small molecules, antibody-drug conjugates (ADCs) and immuno-oncology biologics.

Oncology sales comprise around 27% of its total revenues. Its oncology revenues grew 8% in 2025, driven by drugs like Xtandi, Lorbrena, the Braftovi-Mektovi combination and Padcev, which made up for declining sales of drugs like Ibrance.

Xtandi recorded alliance revenues of $2.19 billion in 2025, up 8% year over year. Lorbrena sales rose 40% to $1.02 billion. Braftovi/Mektovi revenues were $716 million, up 18% year over year. New drug, Elrexfio, generated sales of $304 million in 2025. Ibrance revenues declined 6% year over year to $4.1 billion.

Among the antibody-drug conjugates added from the 2023 acquisition of Seagen, Adcetris sales of $907 million declined 17% year over year due to competitive pressure in the United States. Padcev rose 22% to $1.94 billion, driven by strong demand trends mainly due to market share gains in first-line metastatic urothelial cancer.

Pfizer considers Padcev to be a potential growth driver in the oncology segment and plans to invest in this asset. Recently, Padcev plus Keytruda was approved by the FDA for treating cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC) in November 2025. The approval marked the first and only ADC plus PD-1 inhibitor combination regimen for this patient population and a potential new standard of care. Padcev plus Keytruda is also being studied in cisplatin-eligible MIBC. If approved for cisplatin-eligible MIBC, it will substantially expand Padcev's U.S. eligible patient population.

Pfizer has ventured into the oncology biosimilars space and markets six biosimilars for cancer. Its oncology biosimilars contributed $1.3 billion in sales in 2025, rising 26% year over year.

Pfizer also advanced its oncology clinical pipeline with several candidates entering late-stage development, like atirmociclib and sigvotatug vedotin. Regulatory application seeking approval of sasanlimab is under review in the EU, while that for vepdegestrant is under review in the United States and may be launched next year. By 2030, it expects to have eight or more blockbuster oncology medicines in its portfolio.

Last year, Pfizer entered into a global ex-China in-licensing agreement with China's 3SBio for exclusive rights to PF-08634404, a dual PD-1 and VEGF inhibitor, which it plans to establish as a potential backbone therapy across multiple tumor types. Pfizer plans to start four pivotal studies for PF-08634404 in 2026.

Pfizer is also working on expanding the labels of approved oncology drugs like Padcev, Tuksya, and Elrexfio, among others. Backed by new approvals, label expansions and a deep late-stage pipeline, the company is positioning its cancer franchise for sustained expansion through the end of the decade.