Out of 22 new chemical entities (NCEs) approved by the FDA in 2016, seven were in oncology.1 The new products include four anticancer agents, two diagnostic imaging agents, and one used to treat complications from stem cell transplants. Along with Trade Name, (generic name), and indication, a structural formula or symbol is given for each.
Lartruvo (olaratumab) is used to treat soft tissue sarcoma when it is not amenable to radiotherapy or surgery. The antibody blocks platelet-derived growth fractor receptor alpha (PDGF-Rα) to slow or cease tumor growth.2
Tecentriq (atezolizumab) blocks the Programmed Death-Ligand 1 (PD-L1) receptor to treat locally advanced or metastatic urothelial carcinoma when platinum-containing chemotherapy is not effective.3
Venclexta (venetoclax) is approved to treat Chronic Lymphocytic Leukemia (CLL) in patients with 17p deletion chromosomal abnormality.4
Rubraca (rucaparib) inhibits DNA repair enzyme PARP-1 and will be used to treat advanced ovarian cancer patients with defective BRCA gene.5
NETSPOT (gallium Ga-68 dotatate) is a diagnostic imaging agent used in positron emission tomography (PET) to aid detection of rare neuroendocrine tumors.6
Axumin (fluciclovine F 18) is another diagnostic imaging agent used in PET. It is used to detect suspected prostate cancer recurrence.7
Defitelio (defibrotide sodium) is a variable-length, single-stranded DNA oligonucleotide mixture used to treat patients suffering a complication of hematopoietic stem cell transplantation. The complication, hepatic veno-occlusive disease (VOD), can result from the large doses of chemotherapy administered to transplant recipients prior to the procedure.8
In 2015, 15 of 45 total approved NCE’s were oncology-related.9 John Jenkins, director of the US FDA Office of New Drugs, says not to blame the FDA—with its 800 employee labor shortfall10—for the 2016 downturn in NCEs. He says that the smaller 2016 number is due to drug developers presenting it with fewer submissions. Jenkins said that there was an uptick in submissions received “recently,” which may increase the NCE total in 2017.10
Please note that this is not medical advice.
I updated this post on January 29, 2017 to include all of the drugs approved in 2016. So Rubraca was added to this list.
1. Novel Drug Approvals for 2016. US FDA. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm483775.htm (Accessed 12/16/2016)
2. Label for Lartruvo. US FDA. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761038lbl.pdf (Accessed 12/16/2016)
3. Label for Tecentriq. US FDA. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761034s000lbl.pdf (Accessed 12/16/2016)
4. Label for Venclexta. US FDA. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208573s000lbl.pdf (Accessed 12/16/2016)
5. Press release for Rubraca approval. US FDA. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm533873.htm (Accessed 1/29/2017)
6. Label for NETSPOT. US FDA. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208547s000lbl.pdf (Accessed 12/16/2016)
7. Label for Axumin. US FDA. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208054s000lbl.pdf (Accessed 12/16/2016)
8. Label for Defitelio. US FDA. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208114lbl.pdf (Accessed 12/16/2016)
9. Novel Drug Approvals for 2015. US FDA. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm430302.htm (Accessed 12/16/2016)
10. FDA’s Jenkins on Decline in New Drug Approvals in 2016: Not due to Standards Shift. 4 November 2016. Zachary Brennan. http://www.raps.org/Regulatory-Focus/News/2016/11/04/26130/FDA%E2%80%99s-Jenkins-on-Decline-in-New-Drug-Approvals-in-2016-Not-due-to-Standards-Shift/ (Accessed 12/16/2016)
Antibody image: https://www.cellapplications.com/antibodies
Other figures created by Daniel Beck using ChemDraw