Paramahansa Yogananda, who introduced yoga to the U.S. nearly a century ago, famously said that “the season of failure is the best time for sowing the seeds of success.” That observation could also apply to cancer drug development, the Pharmaceutical Research and Manufacturers of America (PhRMA) said in a new report.
“Researching Cancer Medicines: Setbacks and Stepping Stones,” released yesterday, spotlights the successes and mostly failures over the past 16 years in efforts to treat the more than 200 disorders included within the disease umbrella.
“Researching Cancer Medicines” focuses on efforts to develop new treatments for three forms of the disease: melanoma, lung cancer, and brain cancer. Of cancer medicines and vaccines in clinical or regulatory review, more than 50 are indicated for treatment of melanoma, 98 for lung cancer and 47 for brain cancer.
Between 1998 and September 15 of this year, according to the report, only seven treatments for melanoma had been approved, while another 96 did not survive clinical trials.
The most recently-approved cancer drug is Merck & Co.’s immunotherapy Keytruda (pembrolizumab), which received FDA’s nod on Sept. 4 as the first programmed death receptor-1 (PD-1) inhibitor allowed for use as a drug in the U.S.
Odds of successful drug development were worse in lung cancer, where 10 new medicines made it to market while 167 failed in trials. FDA’s latest approval of a lung cancer drug occurred April 29, when it cleared Novartis’ Zykadia (ceritinib), indicated for metastatic ALK-positive non-small cell lung cancer (NSCLC) who were previously treated with crizotinib.
Even worse, just three brain cancer won approval—none of them this year—while 75 did not survive clinical phases.
Daunting as those odds look, those failures are critical to future cancer drug development, since success is typically the result of cumulative innovation over time rather than a “Eureka!” breakthrough moment, PhRMA concluded.
“While it may sound counterintuitive, research setbacks are instrumental to furthering efforts to better understand a disease and how to treat it. They are also an indication of the incredible difficulty in developing medicines to treat cancer,” PhRMA president and CEO John J. Castellani said in a statement. “These setbacks serve as a reminder that to make progress, we need a public policy framework that supports drug development in combination with promising science so that we can bring important innovations to patients.”
PhRMA did not recommend any specific public policies in its report, which cited 771 new medicines as being in development to fight cancer—a figure cited both in a 2012 PhRMA study and a separate report issued this week.
PhRMA’s new edition of “Medicines in Development: Cancer” noted that of the top five cancer categories for which drugs were in development, 98 are for lung cancer, 87 for leukemia, 78 for lymphoma, 73 for breast cancer, 56 for melanoma and other types of skin cancer, and 48 for ovarian cancer.
PhRMA released “Researching Cancer Medicines” in advance of the Turning the Tide Against Cancer National Conference, set for tomorrow. During the conference, Castellani will join other healthcare stakeholders to discuss how cancer care and innovation should be advanced.