Tolmar’s expansion of the evidence for Rubraca® outshines Docetaxel

Announcement

Tolmar, Inc. has proudly declared that its extended indication for Rubraca® has finally received the U.S. Food and Drug Administration (FDA) stamp. The extended indication allows its use before chemotherapy for the qualified patients suffering from metastatic castration-resistant prostate cancer (mCRPC). This approval is backed by the crucial TRITON3 Phase 3 trial, which illustrates that Rubraca is the first ever and only PARP inhibitor to cross the efficacy standard of docetaxel in a straight neck-to-neck comparison.

This represents a noteworthy success and positive change in the treatment sequencing for the DNA damage repair (DDR)-deficient tumor patients. The Chief Executive Officer of Tolmar, Anil D’Souza, said, “This approval mirrors a groundbreaking and unforgettable moment for precision oncology and patients. For decades thwe oncologists have been dependent on docetaxel as a fundamental therapy in this space. But now the TRITON3 has the potential of Rubraca as not only the solution that is ahead of chemotherapy, but has also outshone docetaxel.”

“Rubraca is backed by the greatest progression-free survival and clear genomic rationale. Introducing Rubraca early in the treatment journey provides a more concentrated approach for physicians for patients suffering from BRCA-mutated prostate cancer.”

About TRITON3 study

The TRITON3 study is a shuffled, best-in-class, multicenter Phase 3 trial of rucaparib in chemotherapy-naïve mCRPC patients. The patients who are first treated with an androgen receptor antagonist therapy. Further, the study has registered 405 patients having a mutation in ATM or BRCA who were shuffled to the control group or rucaparib. This group included the physician’s choice of abiraterone acetate, enzalutamide or docetaxel. Around 55% of the patients registered under the control arm received docetaxel.

The initial stage was radiographic progression-free survival (rPFS) by independent radiology review (IRR) in patients suffering from mutations in ATM, BRCA1 or BRCA2. The TRITON3 study was engineered as a Phase 3 trial to extend and confirm the efficacy data from its previous TRITON2 in an earlier treatment space in mCRPC against a familiar control arm. The patients were confirmed for the therapy related to an FDA-qualified supportive diagnostic for rucaparib.

The major findings consist of Rubraca tolerability profile, superiority in Radiographic progression-Free Survival (rPFS) and compelling evidence of the genomically determined benefit. Prostate cancer is the most commonly diagnosed cancer in the U.S. male population, with the registration of around 313,780 new cases this year. Following this, the approval of the new extended indication approval is a development in the treatment of the oncology space.