The Gap in Oncology Formulary Decision Support Coverage

The American Society of Clinical Oncology (ASCO) lists more than 120 types of cancer and related hereditary syndromes.

Tools are available that provide comparisons of available drug products. Such tools may include a drug’s comparative efficacy, therapeutic role and class monographs to assist with drug therapy decisions once a product is available. Clinicians can access services that detail the information, including access to past reviews, about recently released and investigational drugs projected for approval in the near term.

But how does a formulary management team assess and prepare for perhaps eight new oncology drugs this year? FDA publications? PubMed feeds? Google alerts? Would it help to have a single source of unbiased, comprehensive clinical decision support information in one place?

The Prescribe Right Pharmaceutical Pipeline Tracker contains 157 investigational cancer drugs. There are twenty-one different categories of cancer drugs in our knowledgebase. The ten most common cancers represent 85% of the cancer investigational drug universe: Bladder, Breast Cancer, Colorectal Cancer, Kidney Cancer, Lung Cancer, Lymphoma, Melanoma, Pancreatic Cancer, Prostate Cancer, and Thyroid Cancer.

How does your current process provide coverage of investigational oncology drugs? Do you have a single source that is comprehensive, unbiased, with actionable intelligence? The Pharmaceutical Pipeline Tracker provides concise summaries of clinical trials that not only includes the results, but also the type of patient that was treated and any safety issues that may be present.

Here’s a look at eight oncology drugs that appear to be on the approval near horizon. Comments are taken from the Pharmaceutical Pipeline Tracker knowledgebase:

Quizartinib for acute myeloid leukemia with a PDUFA of May 25, 2019 has Orphan Drug, Breakthrough Therapy and Fast Track Priority Designations. Single-agent quizartinib was shown to be highly active and generally well tolerated in patients with relapsed or refractory acute myeloid leukaemia, particularly those with FLT3-ITD mutations. These findings confirm that targeting the FLT3-ITD driver mutation with a highly potent and selective FLT3 inhibitor is a promising clinical strategy to help improve clinical outcomes in patients with very few options.

Selinexor for multiple myeloma with a July 6, 2019 PDUFA Date has Orphan Drug and Fast Track Priority. The combination of selinexor and dexamethasone has an ORR of 21% in patients with heavily pretreated, refractory myeloma with limited therapeutic options.

Pexidartinib for tenosynovial giant cell tumor with an August 3, 2019 PDUFA Date has Orphan Drug and Breakthrough Therapy Priority Designations. Pexidartinib is also being evaluated for glioblastoma, ovarian, breast, colorectal, pancreatic and prostate cancer, malignant peripheral nerve sheath tumor, and pediatric cancers.

Entrectinib for NTRK‐fusion+ solid tumors with an August 18, 2019 PDUFA Date has Breakthrough Therapy Priority Designation. Roche is seeking approval based on an integrated analysis from four Phase I and II trials that included data from 53 people with ROS1-activating gene fusions and 54 people with locally advanced or metastatic NTRK fusion-positive solid tumors. If approved, entrectinib would compete with larotrectinib to treat NTRK-fusion positive solid tumors and critzotinib to treat ROS1-mutated non-small cell lung cancer.

Polatuzumab for diffuse large B-cell lymphoma with an August 19, 2018 PDUFA Date has Breakthrough Therapy Priority Designation. Current trial data display no significant safety concerns, no independent safety data are yet available. The most common ADR in an 80 patient, Phase II trial were leukopenia, thrombocytopenia and anemia.

Fedratinib (Celgene, Impact Biomedicines) for myelofibrosis with a September 3, 2019 PDUFA Date has no Priority Designations. Sanofi discontinued development of fedratinib in 2013 after the FDA issued a clinical hold due to reports of Wernicke’s encephalopathy in clinical trials. Impact provided safety data to the FDA and the trial resumed. Celgene bought Impact in January 2018.

Erdafitinib for urothelial cancer with a Breakthrough Therapy Priority Designation but no PDUFA date. Janssen submitted an NDA in September 2018. Janssen has the ongoing 630 patient, Phase III THOR trial evaluating erdafitinib compared to chemotherapy or pembrolizumab for the treatment of urothelial carcinoma.

Darolutamide for prostate cancer has no PDUFA Date nor Priority Designations. There are direct links to three published studies in PubMed for Darolutamide in the Pharmaceutical Pipeline Tracker.