Noted This Week
Cancer-related news briefs by week
January 20, 2017
- An NIH spokesman announced that Francis Collins, MD, will continue to serve as the director of the NIH—at least temporarily. It remains unclear whether President Donald Trump will formally reappoint Collins or eventually name a successor.
- The U.S. Department of Health and Human Services’ Office of Human Research Protections published a revised, final version of the so-called Common Rule, originally promulgated in 1991, to modernize and strengthen regulations that protect people who take part in scientific studies. Among other changes, the final rule establishes new requirements regarding information that must be given to prospective participants as part of the informed consent process, and it allows for the use of “broad consent,” meaning that subjects agree to the use of their information in unspecified future research. The rule goes into effect on January 19, 2018.
- The U.S. Supreme Court announced that it will wade into a dispute between Sandoz and Amgen regarding when approved biosimilar versions of drugs can be brought to market. A lower court made Sandoz wait 180 days to sell Zarxio (filgrastim-sndz), a biosimilar version of Amgen’s Neupogen (filgrastim), after earning approval from the FDA; Sandoz has argued that giving Amgen 180 days’ notice prior to marketing the drug was sufficient and that the company shouldn’t have to wait another 6 months following FDA approval to sell its product.
- The FDA issued a guidance document for industry on the nonproprietary naming of biologic products. The nonbinding recommendations call for the use of a “distinguishing suffix” composed of four lowercase letters “devoid of meaning” at the end of names for “originator biological products, related biological products, and biosimilar products containing related drug substances when other means to track a specific dispensed product are not readily accessible or available.” The distinguishing suffixes should, according to the agency, “help minimize inadvertent substitution of any such products that have not been determined to be interchangeable.”
- The FDA also published drafts of several other guidance documents for industry. These include documents titled “Multiple Endpoints in Clinical Trials,” “Considerations in Demonstrating Interchangeability with a Reference Product,” and “Medical Product Communications That Are Consistent with the FDA-Required Labeling—Questions and Answers.” Comments on the draft documents can be submitted electronically at www.regulations.gov.
- Following the presidential election in November, the FDA announced that it would not release a final guidance document on the regulation of laboratory-developed tests (LDT). This week, however, the agency issued a “discussion paper” on LDTs to synthesize comments it received following the publication of a draft document in October 2014 that was designed to balance concerns about overlapping and burdensome regulations with fears that a lack of oversight could compromise patient safety. According to the FDA, the document is meant to promote public discussion about LDT management; it contains no enforceable provisions.
- Reuters reported that 22 of the world’s largest drug companies will contribute seed funding of $50 million over the next 3 years to a World Bank project to fight cancer and other noncommunicable diseases in poor countries. Dubbed Access Accelerated, the initiative was announced in Davos, Switzerland, during the World Economic Forum.
- The Princess Margaret Cancer Foundation and the Princess Margaret Cancer Centre at University Health Network in Toronto, Canada, successfully concluded their “Billion Dollar Challenge” ahead of schedule. In less than 5 years, the organizations secured $532 million in philanthropic support and $520 million in research grants. The money will support personalized cancer medicine, including the expansion of research in epigenetics, bioinformatics, and immunotherapy.
January 13, 2017
- Takeda Oncology acquired ARIAD Pharmaceuticals for $5.2 billion. The Japanese company has been looking to replenish its oncology portfolio, with its patent on bortezomib (Velcade), a blockbuster drug for multiple myeloma, expiring this year. This deal nets Takeda two key drugs: ponatinib (Iclusig), approved for chronic myeloid leukemia and Philadelphia chromosome–positive acute lymphoblastic leukemia; and brigatinib, an investigational ALK inhibitor under FDA review for non–small cell lung cancer (NSCLC).
- The NCI Formulary, a public–private partnership between the agency and the pharmaceutical industry, launched with 15 targeted drugs from six companies. The formulary will enable researchers at NCI-designated cancer centers to more quickly access approved and investigational agents for preclinical studies and clinical trials—an otherwise lengthy negotiation process that can take up to 18 months. The NCI expects to double the number of participating companies and available drugs by the end of 2017.
- Smoking costs the global economy more than $1 trillion annually in healthcare expenditures and lost productivity, according to a report from the World Health Organization and the NCI. By 2030, the number of tobacco-related deaths is projected to increase by a third—from 6 million to 8 million annually—with more than 80% of these occurring in low- and middle-income countries.
- The FDA granted Priority Review to Merck’s PD-1 inhibitor pembrolizumab (Keytruda) combined with pemetrexed plus carboplatin as first-line treatment for advanced or metastatic NSCLC, with a decision expected by May 10. If approved, this could be the first regimen combining chemotherapy with an immunotherapeutic agent for lung cancer, the company said.
- The FDA also granted Priority Review to Roche’s atezolizumab (Tecentriq) as first-line treatment for patients with advanced or metastatic urothelial carcinoma who are ineligible for cisplatin chemotherapy. The PD-L1 inhibitor is currently approved for treating patients with bladder cancer or NSCLC whose disease has progressed during or following platinum-based chemotherapy. A decision is expected by April 30.
- According to a study in Cancer, mammography rates increased among women 70 years of age or older under the Affordable Care Act (ACA). The ACA eliminated out-of-pocket expenses for this preventive service, resulting in more women across all income and education levels opting to be tested, the researchers reported. However, there were no appreciable changes in the rates of colonoscopy, also free under the ACA; the researchers noted that “other procedural factors may remain as deterrents”—for instance, the test’s invasiveness.
January 6, 2017
- The American Association for Cancer Research’s (AACR) Project Genomics Evidence Neoplasia Information Exchange (GENIE) made public nearly 19,000 deidentified genomic records collected from patients with cancer who were treated at one of eight renowned medical centers in the United States, Europe, or Canada. The data cover 59 types of cancer, including genomic information on almost 3,000 patients with lung cancer, more than 2,000 patients with breast cancer, and more than 2,000 with colorectal cancer. Data from Project GENIE, which was launched in November 2015, can be accessed through the AACR at www.aacr.org or downloaded from Sage Bionetworks.
- In an interview with the Washington Post, Vice President Joe Biden said he will create a nonprofit organization so he can continue to focus on cancer issues after leaving office. He indicated his desire to “get Congress and advocacy groups to make sure [cancer] treatments are accessible for everyone … and that we have a more rational way of paying for them while promoting innovation.” He added that the new nonprofit, tentatively called the Biden Cancer Initiative, will be based in Wilmington, DE, or Washington, DC.
- The cost of cancer drugs is the top challenge to cancer care, according to 83% of respondents to the Association of Community Centers’ seventh annual Trends in Cancer Programs survey; last year, 45% of respondents cited drug costs as the most significant challenge. A lack of reimbursement for supportive care services, such as survivorship care and financial counseling; the need for greater understanding among patients of what commercial insurance policies will cover; the burden of paperwork; and the need for greater, sustained funding for cancer research rounded out the top five issues.
- According to a study published in JAMA Dermatology, the national incidence of melanoma in the United States continues to increase, but states in the Northeast are bucking that trend. Between 2003 and 2013, melanoma incidence dropped in five of the region’s nine states—Vermont, Rhode Island, New Hampshire, Connecticut, and Massachusetts. The researchers attributed the decline to strong prevention efforts by groups such as the Melanoma Foundation of New England.
- Halozyme Therapeutics in San Diego, CA, reported positive data from a phase II study of its investigational drug PEGPH20 in advanced pancreatic cancer. PEGPH20, a PEGylated form of recombinant human hyaluronidase, is designed to temporarily degrade hyaluronan—a dense component of the tumor microenvironment that constricts blood vessels around cancer cells and impedes drug delivery. In the study, PEGPH20 plus nab-paclitaxel (Abraxane; Celgene) and gemcitabine nearly doubled median progression-free survival—from 4.5 months to 8.6 months—compared with nab-paclitaxel and gemcitabine alone.
- The UK’s drug-cost watchdog, the National Institute for Health and Care Excellence (NICE), OK’d the use of pertuzumab (Perjeta; Roche), in combination with trastuzumab and chemotherapy, for the treatment of HER2-positive, locally advanced breast cancer—as long as Roche provides the drug at a discount, the amount of which was not disclosed. Several months ago, NICE rejected coverage of pertuzumab, saying that the cost outweighed the drug’s long-term benefits. NICE said that Roche agreed to a smaller price discount on trastuzumab emtansine (Kadcyla), but the drug was still not deemed cost effective.
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