Pipeline review

This section highlights some of the pipeline drugs expected to be approved by the U.S. Food and Drug Administration (FDA) in late 2019 or early 2020 that may significantly impact clinical practice and/or pharmaceutical costs.

Drug name/ manufacturer

Proposed use

How it works

What’s important

bb2121 / bluebird bio

Treatment of advanced multiple myeloma that has failed or not responded to other therapies

bb2121 is a chimeric antigen receptor T-cell therapy (CAR-T) immune-oncology agent.  CAR-T therapy is a new type of immuno-oncology that harnesses patient’s own immune system to eliminate cancer cells.

Route of administration: IV injection

Benefit coverage: Medical

Anticipated FDA decision: 4Q2019 or early 2020

US sales forecast in 2024: $399M

luspatercept / Acceleron Pharma, Inc.

Treatment of Beta-Thalassemia, an ultra-rare genetic blood disorder that causes severe anemia

Luspatercept is the first treatment designed to repair the red blood cell (RBC) production defect that causes Beta-Thalassemia and restore RBC production. It works by targeting specific proteins involved in late-stage red blood cell production and significantly reducing or eliminating the need for frequent and lifelong blood transfusions.

Route of administration: Subcutaneous (SC) self-administered injection

Benefit coverage: Pharmacy

Anticipated FDA decision: 4Q2019

US sales forecast in 2024: $483M

valoctogene roxaparvovec / BioMarin Pharmaceutical, Inc.

Treatment of hemophilia A

Valoctogene is a one-time gene therapy treatment  designed to replace the missing gene that causes hemophilia A, thereby restoring normal blood clotting function and eliminating the need for lifelong factor replacement therapy.

Route of administration: IV injection

Benefit coverage: Medical

Anticipated FDA decision: 4Q2019 or early 2020

US sales forecast in 2024: $657M

Notes:
U.S. sales forecast provided by EvaluatePharma. www.evaluatepharma.com Accessed February 4, 2019
Benefit coverage is based on currently available information and could change pending final FDA-approved prescribing information.

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