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

Suggested Articles

The data, from two patients with severe blood disorders, are "promising” for what could be a one-and-done treatment, Cantor Fitzgerald analysts wrote.

The fund will back pharma companies as well as developers of medtech products and providers of outsourced services.

The money will fund work to develop polymers in multiple indications and an associated U.S. expansion.