Radar on Specialty Pharmacy
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Scemblix Is First-in-Class STAMP Inhibitor for CML
The FDA recently approved a first-in-class agent for the treatment of chronic myeloid leukemia (CML). The drug’s novel mechanism of action may offer an improvement over other therapies within the class, industry experts say.
On Oct. 29, the FDA approved Novartis Pharmaceuticals Corp.’s Scemblix (asciminib) for the treatment of CML in two indications: (1) adults with Philadelphia chromosome-positive CML in chronic phase previously treated with at least two tyrosine kinase inhibitors (TKIs), which was given accelerated approval, and (2) adults with PH+ CML-CP with the T315I mutation, which was granted full approval. It is the first FDA approval of a CML therapy that is a Specifically Targeting the ABL Myristoyl Pocket (STAMP) inhibitor.
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Two More Accelerated Approval Indications Are Being Pulled
Within the span of one week, Secura Bio, Inc. has revealed that it will withdraw one oncology drug from the U.S. market, as well as an indication for another oncolytic. The FDA had given both accelerated approval. The moves come amid growing scrutiny of that approval pathway, and they mark the ninth and 10th oncology indications and/or drugs taken off the U.S. market since December 2020.
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BCBST, Oncology Group Launch Oncology Medical Home
BlueCross BlueShield of Tennessee (BCBST) and community oncology practice Tennessee Oncology recently launched a value-based cancer care program aimed at providing high-quality, cost-effective health care. The oncology medical home (OMH) will be a model for future programs, says the Blues plan.
The initiative launched in October for BlueCross commercial networks P, S and L members. It will support members beginning with their diagnosis and then through treatment and follow-up care. The partners will work to make sure that best practices in care planning and treatment are followed, that care guidelines are met, that patients get the correct treatment at the right time and that patient-centered care is provided.
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New FDA Approvals: FDA Approves Besremi | Dec. 9, 2021
Nov. 12: The FDA approved PharmaEssentia Corp.’s Besremi (ropeginterferon alfa-2b-njft) for the treatment of adults with polycythemia vera. It is the first interferon therapy that the agency has approved specifically for the condition. The drug received orphan drug designation for the indication. The recommended starting dose is 100 mcg by subcutaneous injection every two weeks. The dose can be increased by 50 mcg every two weeks up to a maximum of 500 mcg until hematological parameters are stabilized.
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News Briefs: Alignment Health Plan will cover Grail’s Galleri liquid biopsy | Dec. 9, 2021
Alignment Health Plan and Grail, LLC signed an agreement that will provide its members access to Galleri, a multicancer early detection blood test. Alignment is a national Medicare Advantage (MA) plan from Alignment Healthcare. The deal makes it the first MA plan to offer the liquid biopsy, which is used as a complement to recommended single cancer screenings and can detect more than 50 types of cancer. It is available by prescription only. New and existing plan members in select HMO and PPO plans in California and North Carolina will have access to Galleri starting Jan. 1.
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