TG Therapeutics Gets Conditional FDA Okay for its First Lymphoma Drug

TG Therapeutics is bringing to the market a new lymphoma drug that is part of an emerging class of therapies aimed at limited cancer cell growth. On February 8th, the Food and Drug Administration conditionally approved TG’s PI3K and CK1 inhibitor Ukoniq for two types of blood cancer.

Ukoniq can treat patients with relapsed or refractory marginal zone lymphoma (MZL) who have undergone at least one prior anti-CD20-based regimen and patients with follicular lymphoma who have failed at least three previous systemic treatments. This is the first and only inhibitor of PI3K delta and CK1 epsilon that can be taken orally.

Looking at the unmet need in the field, the FDA granted conditional approval to the drug based on an overall response rate of the drug derived from the Phase 2 UNITY-NHL trial. The drug showed a response in 49% of MZL patients and 43% of FL patients. However, continued approval of the drug will depend on whether the drug continues to show this response in the confirmatory trial.

But in the meantime, the company will start rolling out the new medication next week at $15,900 for a 30-day supply. For a quick and easy launch, the company has built out a commercial team “who will immediately start to engage customers to educate them on Ukoniq and how to access the product for patients in need,” CEO Michael Weiss said in a statement.

“Despite treatment advances, MZL and FL remain incurable diseases with limited treatment options for patients who relapse after prior therapy and no defined standard of care. With the approval of umbralisib, we now have a targeted, oral, once-daily option, offering a needed treatment alternative for patients,” stated Dr. Nathan Fowler, Professor of Medicine at The University of Texas MD Anderson Cancer Center and the Study Chair of the UNITY-NHL MZL &FL cohorts.

At the current cost, Ukoniq is costlier than the other PI3K inhibitors in the market, including Gilead’s Zydelig, Verastem Oncology’s Copiktra, and Bayer’s Aliqopa. However, unlike these drugs, Ukoniq is a dual inhibitor. The drug inhibits two enzymes, phosphoinositide 3-kinase (PI3K) delta and casein kinase 1 epsilon, both of which play important roles in cancer progression.

The drug also bears a favorable safety profile, which according to the company, will help differentiate the drug from others in the market that has been facing challenges with safety. The company shows that 18% of trial patients reported a serious side effect. The drug’s box will include warnings for severe infections, hepatoxicity, and embryo-fetal toxicity, among other potential side effects.

Struggling PI3K market

The global phosphoinositide 3-kinase inhibitors market is projected to grow at a CAGR of 4.65% in the next 5 years. This growth will be fueled by recent launches and approvals of targeted therapies in the field, including Gilead’s Zydelig, Bayer’s Aliqopa, and Verastem’s Copiktra.

However, the field is plagued by safety concerns and weak efficacy, which has kept the growth rate of the field low. Gilead’s pioneering Zydelig got slapped with a black box warning on serious and sometimes fatal toxicities, forcing an end to its quest to complete frontline trials.

Roche and Novartis each dumped or passed off a PI3K delta drug for safety concerns. Unhappy with the drug, Novartis sold another PI3K delta inhibitor for a meager sum of $20 million. While it is a little premature to assume whether TG Therapeutics’ drug will hold a better stand in the market, it certainly is a good contender, which can go on for long.

Related Article: Two Clinical-Stage Biopharmas Enter Agreement to Develop Drug for Hematologic Malignancies

References

1. https://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-announces-fda-accelerated-approval-ukoniqtm

Author

Ruchi Jhonsa