Abstract
A collection of recently published news items.
Merck will buy Peloton Therapeutics for $1.05 billion up front in a deal that could earn Peloton up to $1.15 billion more in milestone payments. Merck will gain access to Peloton's experimental therapies including PT2977, a HIF2α inhibitor that has shown promise in treating metastatic renal cell carcinoma.
The FDA approved the first PI3K inhibitor for breast cancer—alpelisib (Piqray; Novartis). Combined with fulvestrant, the drug treats men and postmenopausal women with HR-positive, HER2-negative, PIK3CA-mutated, advanced breast cancer whose disease has worsened after an endocrine-based regimen. In the pivotal phase III SOLAR-1 trial, patients who received the combination had a median progression-free survival of 11 months, compared with 5.7 monthsfor patients who received a placebo plus fulvestrant.
Many randomized clinical trials for cancer drugs may not use optimal control arms (JAMA Oncol 2019 May 2 [Epub ahead of print]). Researchers analyzed 98 multiarm trials that led to 96 drug approvals between 2013 and 2018 and found that 16 approvals were based on trials with suboptimal control arms. Of these control groups, 10 used an inferior agent or didn't allow combinations, and four limited the investigator's choice.
Television ads will be required to include prices for certain prescription drugs covered by Medicare or Medicaid. The rule, issued by the Centers for Medicare & Medicaid Services, requires commercials to include prices for drugs that cost more than $35 for a month's supply or for a typical course of therapy.
The U.S. District Court in Boston, MA, ruled that two U.S. scientists should be listed as inventors on six cancer immunotherapy patents. The court determined that the patents, previously issued to Ono Pharmaceutical and Tasuku Honjo, MD, PhD, of Kyoto University in Japan, should also include Gordon Freeman, PhD, of Dana-Farber Cancer Institute in Boston, MA, and Clive Wood, PhD, of Boehringer Ingelheim. The patents describe the PD-1 pathway, the foundation of the PD-1 inhibitor nivolumab (Opdivo; Bristol-Myers Squibb).
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