NCI launches new cancer drug formulary to speed combo trials

Dive Brief:

  • The National Cancer Institute (NCI) on Wednesday launched a new partnership with the NIH and six pharma companies aimed at speeding up clinical trials testing combinations of cancer drugs. 
  • Through the newly created NCI Formulary, investigators at certain cancer centers will be able to more easily request access to and obtain targeted cancer therapies using the NCI as a middleman.
  • Currently, investigators would need to negotiate access directly with pharmaceutical companies — a process which can take months. The NCI Formulary streamlines that process, allowing investigators to more quickly obtain treatments on its list. 

Dive Insight:

Importantly, the NCI Formulary will allow investigators to test listed medications in combination with each other, even if the drugs in question are from different companies. As investment has poured into oncology in recent years, researchers (and companies) have become more interested in the potential of drug combinations to boost response rates. 

Checkpoint inhibitors, for example, have wowed the industry with promising efficacy in certain cancers, but they only work well among patients with specific traits, such as high levels of PD-L1. Combinations, some hope, could overcome these limitations and broaden the patient population that benefits from the treatments. 

The NCI Formulary launched with fifteen drugs on its list, including nine from Roche's Genentech unit and two from Bristol-Myers Squibb. Notably, Roche's checkpoint inhibitor Tecentriq (atezolizumab) and Bristol-Myers' Yervoy (ipilimumab) and Opdivo (nivolumab) are on the list.

Also included are Roche's older mainstays Herceptin (trastuzumab) and Avastin (bevacizumab), as well as some of its newer drugs like Perjeta (pertuzumab) and Gazyva (obinutuzumab). Eli Lilly added two experimental drugs to the formulary.

One glaring exception from the initial group is Merck's checkpoint inhibitor Keytruda (pembrolizumab).

But the NCI hopes to greatly expand the list in the near future.

"By the end of 2017, we expect to have doubled the number of partnerships and drugs available in the NCI Formulary," said James Doroshow, NCI deputy director for clinical and translational research.

Companies still need approved use of their drugs before investigators can begin testing, though the NCI hopes it can facilitate and improve the efficiency of agreements between researchers and companies. 

The NCI Formulary is also part of the NIH's efforts to achieve the goals laid out by Vice President Joe Biden's Cancer Moonshot initiative. 

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