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Oncology Agents of 2016: A Clinical Review

Posted by Denika Hockenhull on December 5, 2016 at 1:34 PM

Oncology management has evolved due to approval of new oncologic agents and their expensive costs. Previously, limited medication availability left practitioners with minimal options for cancer treatment. Newer cancer agents are designed to improve a patient’s quality of life and hopefully, overall outcome. With the rapid development of new oncologic medications, the management process has posed a challenge to physicians and payers. Providing oncologic medications in the most cost-effective manner requires cost-management strategies to weigh the benefits and risks.

Specialty drugs to treat rare conditions and complex diseases, such as cancer, have accounted for a majority of FDA approvals over the past few years. This trend continued into 2016 as drug manufacturers allocated more resources to develop these specialized treatments. HID provides the following clinical review of the most recent oncology medications approved or re-indicated by the FDA. Between April and August of 2016, the FDA has approved the following six oncologic medications for market entry:

Lymphatic Agents


Opdivo (nivolumab) is a fully human monoclonal antibody. This medication works to inhibit PD-1 activity, associated with cell death, allowing the restoration of normal T-cell and immune response. The recommended dosing schedule of nivolumab is 3 mg/kg intravenously every 2 weeks, until disease progression or unacceptable toxicity. A vial of 100mg/10mL costs approximately $3000.

Venclexta (venetoclax) is designed to inhibit BCL-2, an anti-apoptotic protein. BCL-2 is associated with chemotherapy resistance and tumor survival in those with chronic lymphocytic leukemia. The tablet starter packs cost roughly $2500. The patient must have failed at least one prior therapy to be eligible for Venclexta.


Renal Agents


The two new agents for renal cell carcinoma are Cabometyx and Lenvima.

Cabometyx (cabozantinib) is a tyrosine kinase inhibitor, which inhibits vascular endothelial growth factor (VEGF). It works by inducing apoptosis of cancer cells, suppressing metastasis, angiogenesis and tumor growth (Yakes, 2011). It is used for the treatment of advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy. Initial therapy is 60 mg oral tablets once daily, to be continued as long as clinically beneficial or until unacceptable toxicity occurs (Choueiri 2015). The cost for 30-60 mg tablets is $16,500.

Lenvima (lenvatinib) is a tyrosine kinase inhibitor, inhibiting vascular endothelial growth factor (VEGF). When combined with everolimus, lenvatinib has demonstrated increased antitiumor activity by decreasing human endothelial cell proliferation, tube formation and VEGF signaling. Dosing is 18 mg oral capsules once daily. The cost of the starter pack is ~$14,000. Novartis has announced collaboration to combine everolimus with Lenvima due to public pressure to reduce pricing. Lenvima is indicated in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti‑angiogenic therapy. Therapy packs available from Eisai vary by total daily dose of 8, 10, 14, 18, 20, and 24 mg.


Skin Agents


Approved for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), Keytruda (pembrolizumab) is an anti-PD-1 monoclonal antibody. The role of the medication is to reverse T-cell suppression and induce antitumor responses. The drug regimen is to give 200 mg intravenously once every 3 weeks, until disease progression or unacceptable toxicity. A 4mL vial of Keytruda costs around $5300.


Urinary Agent


Tecentriqu (atezolizumab) is an anti-PD-1 monoclonal antibody that works by restoring anti-tumor T-cell function. Typical dosing is 1200mg every 3 weeks (Rosenberg 2016) until disease progression or unacceptable toxicity; 20mL vial roughly under $11000. Tecentriqu is used for the treatment of metastatic urothelial carcinoma in patients who have failed platinum-based chemotherapy.



With already evolving methods, powerful breakthroughs, and technological innovation bolstered by White House support, it is expected that we could see a seismic shift in our understanding of cancer and how to treat it. Over time, we expect advancements in the treatment of both common and rare cancers, which will lead to longer patient survival and improved quality of life.

Yet many new and innovate treatments are entering the market at regular intervals. With innovation comes new costs and plans should be cognizant of advancements in large and high-cost clinical segment. Understanding the landscape of today’s clinical therapy/pathways assists will better assist plans in strategizing for the future.

Topics: drug costs,, pharmacy spend, Specialty Drug, High Cost Medications, Specialty Drug Cost Control, oncology, new cancer drugs, oncology medication, new oncology drugs, oncologic agents, FDA drug approvals

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