Top 3 Things You’ll Learn
- New cancer drugs pending FDA approval in 2021
- Two types of prescription drug pipelines to watch
- Top drugs already approved seeking new indication for treating cancer
In a year of COVID-19 and the race to an effective vaccine, news about several breakthrough treatments for cancer got lost in the mix. Despite the obstacles posed by the pandemic, researchers behind the scenes did not cease to achieve advancements in treating one of the world’s most devastating diseases. New and potentially lifesaving or life-prolonging therapies are reviewed and approved every year, but generally there are two drug pipelines to monitor:
- The novel drug pipeline: drugs that have not been approved by the Food and Drug Administration (FDA) for any cancer indication.
- The indication pipeline: medications that have current FDA-approved indications for cancer whose scope will now expand to additional indications that may include different types of cancer. Often, existing medications that exhibit current financial success for the manufacturer will have an indication pipeline designed to preserve the drug manufacturer’s market share for that that drug for years to come.
News of several innovative cancer treatments took a backseat to COVID-19 and vaccine development in 2020. As new drugs hit the market this year, look out for these breakthrough cancer therapies that may be making headlines in 2021 and beyond.
Here is a look at some of the biggest cancer therapies that may make headlines this year.
New Novel Drugs Pending FDA Approval
- Ygalo® (melflufen): the treatment of multiple myeloma that is refractory to a proteasome inhibitor, an immunomodulatory agent, and an anti-CD28 agent, in combination with dexamethasone.
- Fotivda® (tivozanib): the treatment of relapsed or refractory renal cell carcinoma.
- Idecabtagene vicleucel: a CAR-T therapy for the treatment of relapsed or refractory multiple myeloma in adults who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
- Lisocabtagene maraleucel: a CAR-T therapy for the treatment of relapsed or refractory B-cell non-Hodgkin’s lymphoma, including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and follicular lymphoma, in adults who have received at least 2 prior therapies.
- Tepotinib: the treatment of non-small cell lung cancer in patients with MET exon 14 skipping alterations.
Existing Drugs with New or Pending Approved Indications:
- Yervoy®: the treatment of adults with unresectable malignant pleural mesothelioma, as first-line treatment in combination with Opdivo® (nivolumab); weight-based dose by indication.
- Tagrisso®: the adjuvant treatment after tumor resection in adults with non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations; expected to cost approximately $18,000 per month.
- Iclusig®: the treatment of chronic phase chronic myeloid leukemia with resistance or intolerance to at least 2 prior kinase inhibitors in adults; expected to cost approximately $20,000 per month.
The Bottom Line:
As new drugs or existing drugs with new indications enter the market this year, managing appropriate use of these high-cost medications will be essential. Employers need a tailored clinical strategy that addresses their risk areas to maintain a sustainable pharmacy benefit moving forward. For example, implementing independent prior authorizations on specialty medications can be a very valuable strategy to help your self-funded clients ensure appropriate utilization of oncology medications.
Sources:
- https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2020
- https://www.esmo.org/meetings/esmo-targeted-anticancer-therapies-virtual-congress-2021
- https://antonhealth.com/2020-specialty-pharmacy-approvals/
- https://www.roswellpark.org/newsroom/202012-cancer-innovation-engine-10-roswell-park-research-advances-look-2021