There’s a new oral taxane drug on the horizon that could be a game-changer for advanced gastric and breast cancer patients. It’s called Tesetaxel — and right now, it’s the leading oral taxane currently in clinical development. Taxanes are the most widely used chemo drugs available, and most cancer patients receive either Taxol (paclitaxel) or Taxotere (docetaxel). Still, these drugs can cause serious allergic reactions or other adverse events. For up to 15% of cancer patients, Taxotere can cause permanent hair loss. The U.S. Food and Drug Administration initially granted Tesetaxel’s manufacturer, Genta Incorporated, a “Fast Track” designation back in 2010. And now that Tesetaxel finally starts Phase 3 clinical trials this month (December 2017), the oncology community is watching.
FDA Grants Fast Track Designation to Newest Taxane Drug, Tesetaxel
In most cases, the FDA’s “Fast Track” designation helps get any new drug on the U.S. market much sooner. Typically, this category includes drugs that treat serious or life-threatening conditions, like cancer, or address currently unmet medical needs. Breast cancer and other forms of gastric cancer fit this bill, along with drug trials for Parkinson’s and Alzheimer’s patients.
Genta’s Phase 2a trial for Tesetaxel back in 2009 showed promising results. Initial clinical trials showed anticancer activity comparable to other, infusion-based competitors. Since it’s an oral medication, Tesetaxel cannot cause the severe infusion reactions commonly seen with other conventional taxanes. Often, infused taxanes cause hypersensitivity, nerve damage, and low blood counts in cancer patients during treatment. In addition, Tesetaxel could help patients avoid the nerve damage that frequently accompanies infusion-based taxane treatments. It’s shown to effectively treat advanced gastric cancer as well as breast cancer with just one pill every 21 days. So what’s taking it so long to reach cancer patients who desperately want an effective, safe alternative to infusion-based taxanes?
Genta Liquidation Delayed Tesetaxel’s Initial Path to Market
The drug’s taking longer than expected to secure FDA approval. However, Tesetaxel’s safety and efficacy aren’t the problem. Original manufacturer Genta (the company that also owned Tesetaxel’s patent) filed for bankruptcy and liquidated its assets in 2012. But thanks to promising clinical trial results, a new company, Odonate Therapeutics, is now pushing Tesetaxel forward. Odonate hopes the new oral taxane will provide a safe, effective option that cancer patients can take orally at home. The CONTESSA Phase 3 clinical trial is double-blind, randomized, and placebo-controlled and ends in 2020. The goal is to provide “quality-of-life-advantages” over current alternatives, meaning this drug comes in a pill instead of an infusion. If the trial succeeds, Odonate will secure a Special Protocol Assessment (SPA) and fast-track it for FDA approval shortly afterward.
New Oral Taxane Drug May Help Patients Who Don’t Respond Well to Infusions
Currently, most cancer patients given taxane drugs receive either Taxotere or Taxol, sometimes within a “chemo cocktail” with other drugs. While both drugs belong to the taxane class, they have very different side effect risks. Taxotere can cause persistent, or permanent hair loss for decades after chemotherapy ends. Hair may not grow back on the scalp, and it may cause eyebrows, eyelashes and body hair to fall out. Taxotere’s manufacturer, Sanofi-Aventis, majorly downplayed this psychological complication in U.S. drug packaging, but listed it for European and Canadian patients. Taxol, Taxotere’s closest competitor, doesn’t cause permanent alopecia — but it can cause nerve damage and other lasting side effects.
If everything goes well in Phase 3 trials, we’ll know soon whether Tesetaxel is safer and more effective than both.
How Permanently Bald Taxotere Patients Can Get Justice and Compensation
If you or a loved one experienced permanent hair loss after finishing Taxotere chemotherapy, you may qualify for compensation. To see within minutes if you may qualify for a cash settlement, fill out your free claim evaluation form now. Once you’ve submitted your information, an experienced lawyer will call to explain how to get the financial compensation you deserve.
Mandy Voisin is a freelance writer, blogger, and author of Girls of the Ocean and Star of Deliverance. As an accomplished content marketing consultant, mom of four and doctor's wife, Mandy has written hundreds of articles about dangerous drugs and medical devices, medical issues that impact disabled Americans, veterans' healthcare and workers' compensation issues since 2016.