Noted This Week

May 11–17

The FDA published a list of pharmaceutical companies that have potentially been withholding drug samples from generic manufacturers, along with the names of the specific therapies. The list includes Novartis’s Afinitor (everolimus) and Tasigna (nilotinib) and Celgene’s Pomalyst (pomalidomide) and Revlimid (lenalidomide), among others. "We hope that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval," said FDA Commissioner Scott Gottlieb, MD.

In the United States, only 1.9% of more than 7 million current and former heavy smokers were screened for lung cancer in 2016, according to findings presented during a media preview for the 2018 American Society of Clinical Oncology Annual Meeting. Researchers analyzed data from the 2016 American College of Radiology’s Lung Cancer Screening Registry, which tracked screening at 1,796 sites throughout the country. Screening rates were highest in the Northeast (3.5%) and lowest in the West (1%).

Exelixis announced that atezolizumab (Tecentriq) plus cobimetinib (Cotellic) did not improve overall survival (OS) in patients with advanced colorectal cancer. The negative results came in the phase III IMblaze370 trial, where the combination failed to prolong OS compared with regorafenib (Stivarga; Bayer), the standard treatment. Atezolizumab has FDA approval for certain bladder and lung cancers, and cobimetinib is approved for advanced melanoma.

Eleven new institutions joined the American Association for Cancer Research’s Project Genomics Evidence Neoplasia Information Exchange (GENIE), an international effort to aggregate and make available next-generation sequencing data from patients’ tumors. Thus far, GENIE has publicly released over 39,000 deidentified genomic records, and it is expected to release data from the new institutions in January 2019.

Men and women may have different responses to immunotherapies, according to a study published in The Lancet Oncology. Researchers analyzed 20 published trials involving 11,351 patients with advanced cancers who were treated with immune checkpoint inhibitors. They found that although the drugs improved OS in both men and women, the efficacy of the drugs, on average, was significantly better in men.

Cellectar Biosciences’ drug CLR 131 received orphan drug designation from the FDA for the treatment of patients with rhabdomyosarcoma, a rare pediatric cancer. The drug is a radioiodinated phospholipid drug conjugate that uses phospholipid ether (PLE) and PLE analogues to selectively deliver radiation to tumor cells. CLR 131 previously received orphan drug and rare pediatric disease designations for neuroblastoma.

More U.S. adults are trying electronic cigarettes (e-cigarettes), but fewer are becoming regular users of the devices, according to a report in JAMA. Researchers analyzed data from 101,175 adults gathered by the National Health Interview Survey and found that the percentage of adults who tried an e-cigarette increased from 12.6% in 2014 to 15.3% in 2016, but the percentage of current regular users decreased from 3.7% to 3.2% over the same period.


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