Pharmacology Update Session Gives Oncology Nurses the Essentials on New Drug Approvals
If it seems like a new oncology drug or indication comes to market every month, you wouldn’t be wrong. The U.S. Food and Drug Administration (FDA) has approved a record number of oncology agents in 2017 and 2018. Teresa Knoop, MSN, RN, AOCN®, assistant director of clinical operations at the Clinical Trials Shared Resource at Vanderbilt-Ingram Cancer Center in Nashville, TN, gave an update on the latest therapies (https://ons.confex.com/ons/2018/meetingapp.cgi/Session/1600) during a session at the 43rd Annual Congress in Washington, DC (https://congress.ons.org/).
Since the beginning of 2017, the FDA has approved 21 cancer treatments (11 solid tumor and 10 hematologic treatments):
- 1 new formulation as liposomal cytotoxic chemotherapy
- 1 radiolabeled somatostatin analog
- 1 androgen receptor inhibitor
- 18 molecularly targeted drugs or immunotherapies
Of the 18 that are molecularly targeted or immunotherapy treatments, one new formulation is subcutaneous, one is a reapproval, two are biosimilars, and two are living cell therapies.
“Living cell therapies are creating a lot of excitement for our patients,” Knoop said.
Biosimilars—biologic products that are approved based on similarity to an already approved reference product—have also been gaining ground in oncology. Knoop explained that to meet the rigorous approval criteria, biosimilars “can only have minor differences in inactive components in the drug.”
Knoop said that it’s normal for nurses to feel overwhelmed at the number of new drugs and indications available, and “if you haven’t used [the drug] in a while, it’s a new drug to you.”
She highlighted that non‐small cell lung cancer treatment has seen significant change recently with the introduction of brigatinib and bevacizumab‐awwb as well as several new drug indications. But she emphasized the importance of testing tissues for genomic mutations to determine the best treatment options.
“You have genomic mutations that drive this cancer,” Knoop said. “What this means is you cannot treat them right away.”
Treatment options for acute myeloid leukemia (AML) have also been making significant strides with four newly approved drugs (liposome encapsulated combination of daunorubicin and cytarabine, enasidenib, midostaurin, and gemtuzumab ozogamicin). “AML is one of our biggest areas of movement,” Knoop said. “So, if you work in the AML world, you are overwhelmed.”
Acute lymphocytic leukemia has two new treatments available: one drug, inotuzumab ozogamicin, and one living cell treatment, tisagenlecleucel, which uses the body’s own T cells to fight cancer.
A biosimilar for breast cancer, trastuzumab‐dkst, was FDA approved, along with a few new indications of existing drugs. (Trastuzumab‐dkst was also FDA approved for HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma).
Cervical and ovarian cancer each had a newly approved drug (bevacizumab‐awwb and niraparib, respectively); bevacizumab‐awwb also was FDA approved for renal cell cancer, glioblastoma, and metastatic colorectal cancer.
Knoop said that nivolumab received numerous new indications, including for melanoma, hepatocellular cancer, renal cell cancer, urothelial cancer, and metastatic colorectal cancer. Urothelial cancer also received a newly approved FDA treatment called durvalumab.
Merkel cell cancer, a rare type of skin cancer, and prostate cancer each had one new FDA-approved treatment: avelumab and apalutamide, respectively.
Non-Hodgkin follicular lymphoma, non-Hodgkin lymphoma and chronic lymphocytic leukemia, and non-Hodgkin large B‐cell lymphoma each have one new treatment: copanlisib, rituximab and hyaluronidase human, and axicabtagene ciloleucel, respectively.
Staying Up to Date
With so many new treatments and indications, “how in the world do we, as nurses, try to make sense of this?” Knoop asked, and provided tips for learning about new cancer therapies:
- Know the type of drug or agent (e.g., small molecule, monoclonal antibody, gene therapy, vaccine, cytotoxic).
- Know the generic name.
- Know the target and what it does normally in the body and what other FDA-approved drugs are similar.
- Know if the drug is personalized to a tumor’s genomic profile.
“If you know the generic name of the drug, you can learn a wealth of information,” Knoop said. She provided helpful hints on how a drug name can tell a lot about what the drug does:
- Nibs: Drugs with “-tinib” in the name are generally tyrosine kinase inhibitors; drugs that have “-rafenib” or “-metanib” means that they are kinase inhibitors targeting the RAF/RAS/MEK pathways; and drugs that use “-denib” in the name are inhibitors of the IDH2 enzyme.
- Ibs: Drugs with “-parib” in the name are PARP inhibitors; drugs with “-lisib” are PI3 kinase inhibitors; drugs with “-degib” are sonic hedgehog pathway inhibitors; “-ciclibs” are inhibitors of CDK 4 and 6; and “-zomibs” are proteasome inhibitors.
- Inostat: Drugs with this suffix are histone deacetylase inhibitors.
- Toclax: Drugs with this suffix are BCL‐2 inhibitors.
Learn more about these newly approved drugs and get the latest updates on additional new drugs as soon as they are approved in ONS Voice’s FDA Updates content area (https://voice.ons.org/topic/us-food-and-drug-administration-fda).