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September 3, 2021

The Honorable Governor Gavin Newsom
State Capitol Building, First Floor
Sacramento, CA 95814
Via: [email protected].


Dear Governor Newsom:

Thank you for the opportunity to submit this letter of support for CA Senate Bill 535 (SB 535) to eliminate prior authorization for biomarker testing for advanced stage cancer patients. The Prostate Cancer Foundation (PCF) appreciates the opportunity to provide input and expertise at this time given the importance of biomarker testing to inform critical decisions for prostate cancer patients. Delays in biomarker testing only exacerbate inequitable access to precision medicine for cancer patients and families urgently awaiting life-saving therapies and cures.

By way of background, PCF is the world’s leading philanthropic organization dedicated to funding life-saving cancer research. Founded in 1993 by Mike Milken, PCF has raised more than $880 million in support of cutting-edge research by more than 2,200 research projects at 220 leading cancer centers in 22 countries around the world. Thanks in part to PCF’s commitment to ending death and suffering from prostate cancer, the death rate is down by 52% and countless more men are alive today as a result. PCF research now impacts more than 73 forms of human cancer.

Prostate cancer remains a substantial burden in California: according to Cancer in California (1988- 2016), a special report issued by the California Cancer Registry, prostate cancer is the leading cancer by prevalence and incidence among men in California, with an estimated 275,731 cases. The American Cancer Society estimates that in 2021 alone, in California more than 25,880 men will be newly diagnosed with prostate cancer, while 4,140 men will die of prostate cancer.

PCF has played a leading role in funding advances in precision oncology for prostate cancer. Precision oncology enables the right treatment to be delivered to the right patient at the right time, rather than patients and providers wasting time and resources on unnecessary and ineffective treatments that could potentially yield more harm than benefit. Biomarker testing provides the crucial information that patients and providers use to assess what treatments may be available—particularly for advanced prostate cancer patients facing urgent, unmet medical needs.

Importance of Biomarker‐directed Care in Prostate Cancer

Genetic testing for inherited mutations in men with advanced and metastatic prostate cancer can yield important information not only about treatment options for the patient, but also notably for his family’s health.

PCF-funded scientists have discovered that there are certain relatively rare genes that run in some families that, when present, may increase a man’s risk of developing prostate cancer; in some cases, these genes lead to the more aggressive forms of prostate cancer. In 2016, a PCF-supported study of men with metastatic prostate cancer found that more than 10% have inherited mutations in cancer risk genes such as BRCA1, BRCA2 and at least 18 other newly-discovered genes that may be important to risk of prostate cancer and other types of cancer. National Comprehensive Cancer Network (NCCN) guidelines recommend testing for inherited mutations in all men with regional or metastatic prostate cancer. If a man discovers that he is a carrier of an inherited mutation in BRCA1, BRCA2, or other genes that increase risk for prostate cancer, this has critical implications for all his family members.

Particularly for men with advanced or aggressive disease—that is, whose disease is most resistant to standard treatment—biomarker or gene mutation directed therapies may be effective and meet a critical unmet medical need, including treatment options made available through cutting-edge clinical trials. In 2020, the FDA expanded targeted treatment approaches for some men with prostate cancer with the approval of olaparib (Lynparza) and rucaparib (Rubraca). These PARP inhibitors, along with immune checkpoint inhibitor drug pembrolizumab (Keytruda), are among the targeted therapies for cancer that require biomarker testing of tissue for initiating the treatment, which is given with curative intent.

Precision medicine science is advancing rapidly, and biomarker testing is integral to matching patients to these therapies in the future. To guide treatment selection in patients with metastatic castration-resistant prostate cancer (mCRPC), clinicians can now use a “liquid biopsy”—a blood test that can detect circulating tumor cells (CTCs) shed by prostate cancer—to evaluate a biomarker called AR-V7 as a predictor of response to androgen receptor-blocking drugs such as abiraterone (Zytiga) and enzalutamide (Xtandi). Use of this biomarker can help patients avoid the side effects and expense of treatments that they are unlikely to benefit from, instead prompting doctors to try other, more promising options.

As you consider SB 535, the Prostate Cancer Foundation writes to highlight the critical role of biomarker testing in selecting treatments for patients with advanced and metastatic prostate cancer, and the strong promise for many more biomarker-driven therapies in the near future with research. Delays in biomarker testing may lead not only to delays in care, but also to suboptimal care for those at highest risk for advanced disease. For these reasons, on behalf of the hundreds of thousands of patients and families living with cancer in California, the Prostate Cancer Foundation strongly urges you to sign SB 535.

Dr. Charles Ryan
Charles J. Ryan, MD
President and Chief Executive Officer

cc: The Honorable Senator Monique Limón, California State Senate