The FDA Approves a new prostate cancer combination treatment based upon a successful clinical trial

The U.S. Food and Drug Administration (FDA) recently approved TALZENNA (talazoparib) in combination with XTANDI (enzalutamide) for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). TALZENNA is the first and only PARP inhibitor approved for use with an existing standard of care (XTANDI) for adult patients with this condition. The FDA’s approval of the combination treatment is based on the findings from the pivotal TALAPRO-2 study, which demonstrated a 55% reduction in the risk of progression or death among HRR gene-mutated tumors in patients with metastatic castration-resistant prostate cancer. This was a trial that PHEN supported through its Clinical Trials Rally. Patients participating in this trial were the first to benefit from its success, while also helping to establish a new treatment protocol that will help other patients along their prostate cancer journeys.

“PHEN is really excited to have supported the trial that led to this treatment breakthrough,” says Dr. Keith Crawford, PHEN’s Director of Clinical Trials and Patient Education.

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PHEN Supports TALAPRO-3 Clinical Trial

PHEN's Clinical Trials Rally's approach of educating Black prostate cancer patients about clinical trials, as well as strategic partnerships with pharmaceutical companies to amplify this message, is contributing to greater diversity among clinical trial participants.

In addition to Pfizer's TALAPRO-2 clinical trial, PHEN also supported its TALAPRO-3 trial. Pfizer reported that they were able to complete this trial's enrollment ahead of schedule which included 20% of Black patients enrolled in the U.S. Pfizer recognized PHEN's support by stating: "This is a testament to the value that you provide and the impact you've had in raising awareness about the studies."

Patient Story: Dewayne Charleston’s Clinical Trial Participation

Dewayne Charleston is a member of PHEN’s Survivor Network who was initially diagnosed with advanced prostate cancer in 2009, and became metastatic castration resistant in 2021. Despite this serious diagnosis, Charleston persevered by pursuing clinical trials. With PHEN’s assistance, Dewayne accessed the clinical trial SPLASH (NCT04647526) for metastatic castration resistant patients. This was a PHEN supported clinical trial sponsored by Point BioPharma.

With this clinical trial and afterwards, Dewayne took an aggressive approach to his treatments and experienced a great level of success. As such, he was able to continue his active life style with a visit to Ghana to volunteer at the local schools.

Pictured:

Dewayne Charleston, Member of PHEN's Survivor Network with children from school in Ghana.

Patient Benefits of Participating in Clinical Trials:

● Clinical trials are additional treatment options

● Clinical trials provide expert medical care

● Patients receive treatment at minimal or no cost

● Patients are among the first to benefit from a new therapy

● Patients will participate in a new treatment discovery

PHEN Clinical Trials Highlights

Drug PF-06821497

For patients with Castration Resistant

Prostate Cancer (mCRPC).

Patient Summary

TAMARACK

For patients with Metastatic Castration Resistant Prostate Cancer (mCRPC).

Patient Summary

Find Your Trial!

PHENTrials.com hosts approximately 500 prostate cancer clinical trials that are categorized for patients to find trials that are a match for where they are on their prostate cancer journey.

Patients can use PHEN’s “Find-Your-Trial” search tool to easily find appropriate trials. PHEN also provides clinical trials navigation support for patients.

Visit: PHENTrials.com