7. Venclexta

Genentech illustration for Venclexta release

Active ingredient: venetoclax
Disease: chronic lymphocytic leukemia in patients with a specific chromosomal abnormality
Peak sales estimate: $1.7 billion
Approved: April 11
Company: AbbVie, Roche

The scoop: Venclexta’s road to market was a speedy one, notching three breakthrough drug designations, orphan drug designation and priority review status before nabbing an accelerated approval in April. It is the first FDA-approved treatment that targets the B-cell lymphoma 2 protein, which promotes cancer growth and is overexpressed in many CLL patients. Specifically, the drug is indicated for CLL patients who also have a chromosomal abnormality called a 17p deletion, who lack a section of the chromosome that curbs cancer growth. The FDA nod was based on a single-arm study involving 106 patients, where four out of five patients had a complete or partial remission of their cancer. AbbVie previously told FierceBiotech that the drug would cost about $109,500 for a year’s supply. While the approval is only for CLL, Venclexta has breakthrough designations for patients with relapsed/refractory CLL and for use in combination with hypomethylating agents to treat patients with untreated acute myeloid leukemia. It’s uncommon for a drug to rack up three separate breakthrough designations, but this can only be good news for Venclexta’s financial prospects. Sales estimates are as high as $2 billion if it earns approval in these indications. —Amirah Al Idrus

7. Venclexta

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