Noted This Week
GlaxoSmithKline (GSK) and the University of California inked a 5-year collaboration to establish the Laboratory for Genomics Research (LGR), which will explore how gene mutations cause disease and develop technologies using CRISPR to accelerate the discovery of new medicines. The LGR, which will receive funding of $67 million from GSK, will focus on immunology, oncology, and neuroscience.
With the patent on trastuzumab (Herceptin; Genentech/Roche) in the United States about to expire, Amgen and Allergan announced that the FDA has approved their biosimilar product, trastuzumab-anns (Kanjinti). The go-ahead from the agency covers all the same indications for which trastuzumab is currently used: as a single agent for the treatment of patients with HER2-overexpressing breast cancer who have received at least one chemotherapy regimen for metastatic disease; in combination with paclitaxel for the first-line treatment of these cancers; or in combination with chemotherapy for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. Trastuzumab-anns is the fifth trastuzumab biosimilar greenlighted by the FDA.
The FDA finalized its guidance document for manufacturers submitting new tobacco product applications for electronic nicotine delivery systems (ENDS), such as electronic cigarettes and the nicotine-containing liquids used with the devices. The document says that, in order to market ENDS products, manufacturers and importers must demonstrate, among other things, that the marketing of the new tobacco product would be appropriate for the protection of the public health—for example, that it is more likely that the devices would assist current tobacco users in quitting than that nonusers, especially children, would become users.
According to an article published in The New England Journal of Medicine, chemotherapy plus radiation is no better than chemotherapy alone for locally advanced endometrial cancer. Previous studies have, the researchers wrote, “supported the feasibility and efficacy of a combined treatment strategy.” However, in the phase III trial, the estimated percentage of relapse-free patients after 5 years in the chemoradiotherapy group was 59%, compared with 58% in the chemotherapy-only group.
Merck’s pembrolizumab (Keytruda) earned FDA approval for yet another indication: first-line treatment of patients with metastatic or inoperable recurrent head and neck squamous cell carcinoma (HNSCC) in combination with platinum and fluorouracil, and as a single agent for patients whose tumors express PD-L1. The agency also expanded the uses of the PD-L1 IHC 22C3 pharmDx kit (Agilent) to include use as a companion diagnostic device to select patients with HNSCC for single-agent treatment with pembrolizumab.
NIH Director Francis S. Collins, MD, PhD, announced that he will no longer participate in all-male speaking panels, noting that women and members of other groups underrepresented in science are often not given marquee speaking slots at scientific conferences and meetings. “Starting now, when I consider speaking invitations, I will expect a level playing field, where scientists of all backgrounds are evaluated fairly for speaking opportunities,” he said. “If that attention to inclusiveness is not evident in the agenda, I will decline to take part.”