Meitheal Pharmaceuticals Inc. announced it has launched, through an exclusive license and supply agreement with its parent company, Hong Kong King-Friend Industry Co. Ltd., paclitaxel protein-bound particles for injectable suspension (albumin-bound), a generic form of Abraxane (Celgene) in the United States.
The 100-mg/vial single-dose presentation of protein-bound paclitaxel for injectable suspension is indicated for the treatment of metastatic breast cancer, metastatic adenocarcinoma of the pancreas, and locally advanced or metastatic non-small cell lung cancer.
“Many patients living with difficult-to-treat cancers are faced with the unfortunate reality that the complex, life-saving treatments they need are too expensive or unavailable. At Meitheal, we’re committed to closing this gap—we believe that today’s launch is critical to ensuring that cancer patients get the medicines they need,” Tom Shea, the CEO of Meitheal, said in a company press release. “We’re excited to bring this [drug] to market in the U.S. and provide patients and providers with a reliable supply of an effective cancer care treatment.”
The launch of paclitaxel increases Meitheal’s portfolio of on-market generic injectables to 68 products, and builds on its successful 12 product launches in 2024, the company noted. In addition to paclitaxel, Meitheal is planning to launch 20 new products this year across its core therapeutic areas as it continues to identify gaps in the marketplace and evaluate opportunities to address the needs of both patients and providers.
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is a microtubule inhibitor indicated for the treatment of metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
The launch announcement cited selected safety information from paclitaxel prescribing information, including a warning about severe myelosuppression. Other safety alerts noted in the release included the following:
• Do not administer paclitaxel protein-bound particles for injectable suspension (albumin-bound) therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm3.
• Monitor for neutropenia, which may be severe and result in infection or sepsis.
• Perform frequent complete blood cell counts on all patients receiving paclitaxel protein-bound particles for injectable suspension (albumin-bound).
• Contraindications include neutrophil counts of less than 1,500 cells/mm3 and severe hypersensitivity reactions to paclitaxel protein-bound particles for injectable suspension (albumin-bound).
• Use caution when concomitantly administering paclitaxel protein-bound particles for injectable suspension (albumin-bound) with inhibitors or inducers of either cytochrome P450 2C8 (CYP2C8) or CYP3A4.
For more warnings and precautions, see the drug’s full prescribing information.