FDA Approvals for the First 6 Months of 2016 Include Clovis’S Rucaparib, Which the Company the FDA Approved 13 New Drugs in the First 6 Months of This Year (TABLE 1)

Nature Reviews Drug Discovery | Published online 29 Jul 2016 NEWS & ANALYSIS

NEWS IN BRIEF

Other PARP inhibitors in development FDA approvals for the first 6 months of 2016 include Clovis’s rucaparib, which the company The FDA approved 13 new drugs in the first 6 months of this year (TABLE 1). These Center for filed for FDA approval in February, Medivation’s Drug Evaluation and Research (CDER) approvals consisted of 8 small molecules and 5 biologics. talazoparib, which is in Phase III trials for breast FDA approvals tend to be back-loaded to the second half of the year. Last year, the FDA cancer and AbbVie’s veliparib, which is in approved 14 new drugs in the first half of the year and 31 in the second half, for a total of Phase III trials for breast cancer and non-small 45 approvals (Nat. Rev. Drug Discov. 15, 73–76; 2016). cell lung cancer. The agency also approved one biosimilar. Celltrion’s infliximab-dyyb became the first Asher Mullard FDA-approved biosimilar of a monoclonal antibody. Asher Mullard Cancer model consortium debuts Table 1 | FDA approvals in the first 6 months of 2016 Drug (trade name) Lead company Indication Although cancer researchers have made Brivaracetam (Briviact) UCB Partial-onset seizures important discoveries with currently available cancer cell lines, several shortfalls limit the Obiltoxaximab (Anthim)* Elusys Therapeutics Anthrax utility of these models. Cell lines don’t exist Ixekizumab (Taltz)* Eli Lilly Plaque psoriasis for all cancer types, and don’t capture the full genetic diversity of any cancer type. Reslizumab (Cinqair)* Teva Severe asthma Two-dimensional models don’t necessarily Defibrotide sodium (Defitelio) Gentium Hepatic veno-occlusive disease reflect the biology of three-dimensional tumours. And a lack of clinical data about Venetoclax (Venclexta) AbbVie Chronic lymphocytic leukaemia how cancer-cell donors responded to Pimavanserin tartrate Acadia Hallucinations and delusions associated treatment complicates interpretation (Nuplazid) Pharmaceuticals with Parkinson’s disease psychosis of preclinical results. Atezolizumab (Tecentriq)* Genentech Urothelial carcinoma To address these deficits, four US and Obeticholic acid (Ocaliva) Intercept Primary biliary cholangitis European organizations are launching the Human Cancer Model Initiative (HCMI) to [18F]fluciclovine (Axumin) Blue Earth Diagnostics Suspected prostate cancer recurrence generate 1,000 new cancer models. Daclizumab (Zinbryta)*# Biogen Multiple sclerosis “This new project is timed perfectly to take advantage of the latest cell culture and Gallium Ga 68 dotatate Advanced Accelerator Neuroendocrine tumours genomic sequencing techniques to create (Netspot) Applications models that are representative of patient Sofosbuvir and velpatasvir Gilead Sciences Hepatitis C virus genotypes 1–6 tumours and are annotated with genomic (Epclusa) and clinical information,” said Louis Staudt, # *Biologics. The FDA first approved daclizumab in 1997 for kidney transplant rejection, but its then-sponsor director of the US National Cancer Institute Roche withdrew the drug in 2009 citing declining demand. (NCI)’s Center for Cancer Genomics, in a press statement. Contributing scientists will also but the newly released data have renewed use reprogrammed stem cells and organoids PARPs pick-up interest in follow-on candidates. — 3D organ-like cell structures — to generate In the Phase III trial of niraparib in patients better models of disease. “This effort is a first Tesaro’s poly(ADP-ribose) polymerase (PARP) with platinum-sensitive ovarian cancer, step toward learning how to use these tools to inhibitor niraparib hit its primary end point median progression-free survival for patients design individualized treatments,” he said. in its first Phase III trial, lifting hopes for with germline BRCA mutations who received The NCI, the Sanger Institute in Cambridge, a class of anticancer drugs with a turbulent niraparib was 21 months compared with 5.5 UK, Cancer Research UK and the Hubrecht history. months in the control arm. Although it is difficult Institute in Utrecht, the Netherlands, are Companies first started working on PARP to compare the results of two different trials funding and contributing to the HCMI. inhibitors in the 1990s. Because PARP proteins — which can include patients with different The initiative will generate models for facilitate the repair of DNA damage, researchers baseline characteristics — investors interpreted common cancers as well as for rare and theorized that PARP inhibitors would lead to these data as a win for Tesaro. In AstraZeneca’s childhood cancers. Cancer models, and accumulation of DNA damage and therefore 2011 Phase II study of olaparib, median associated data sets and annotations, kill highly mutated cancer cells. The field stalled progression-free survival of patients with will be shared with the research community. in 2011 with the Phase III failure of Sanofi’s germline BRCA mutations was 11.2 months, If all goes to plan, the HCMI could eventually iniparib in triple-negative breast cancer, but compared with 4.1 months in the control arm. generate thousands more models as well. made a comeback following the discovery that Tesaro will present full data at the European Researchers may ultimately need about iniparib was not a bona fide PARP inhibitor Society for Medical Oncology (ESMO) congress 10,000 models to fully capture the diversity (Nat. Rev. Drug Discov. 12, 725–727; 2013). in October. It also plans to file for regulatory of relatively common genetic subtypes of AstraZeneca secured a first approval approval in both the United States and the cancer, Staudt told Nature News. for the drug class in 2014 with olaparib, European Union in the fourth quarter of 2016. Asher Mullard