TG Therapeutics stock falls as FDA extends review of blood cancer drug combo

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The U.S. Food and Drug Administration (FDA) extended the review date of TG Therapeutics' (TGTX -5.3%) applications seeking approval of ublituximab plus UKONIQ (umbralisib) to treat patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) to June 25.

The FDA notified the company that the updated overall survival analyses which were submitted to the U.S. regulator in February 2022, is a major amendment to the applications, and the FDA needed more time for full review of the submissions.

The FDA's Oncologic Drugs Advisory Committee is expected to meet in March or April to evaluate data related to the drug.

The company noted that the FDA's concern giving rise to the ODAC meeting appears to stem from an early analysis of overall survival from the UNITY-CLL trial.

The company said overall survival was designated as a secondary efficacy outcome in the UNITY-CLL protocol but was not part of the primary analysis and therefore, was not analyzed or included in the Biologics License Application (BLA) and supplemental New Drug Application ((sNDA)). And the study was not powered for overall survival.

The company added that as part of the ongoing review of the BLA/sNDA, the FDA requested an early analysis of overall survival from the UNITY-CLL trial and as of September 2021, there was an imbalance in favor of the control arm

However, when excluding deaths related to COVID-19, the two arms were nearly balanced.

In February 2022, the company submitted updated overall survival data with the same September 2021 cut-off date.

Comments

[Robert1942]

Isn’t this exactly the same issue that blew their drugs for CLL out of the water?We were misinformed by the CEO at that the disparity in OAS was secondary to deaths from covid in immunocomprimised patients. I think it shows the FDA is incompetent at that it is very difficult to run any drug study during a pandemic where the patients are by definition, immunocompromised.

[Arabian Horses]

Clearly the FDA is incapable of completing a BLA on time as this is the umpteenth company facing this same issue. While COVID is serious and needs the attention of the FDA, so are other disease that need therapeutic options available. This response is becoming a broken record from the FDA. In 30 years I have not seen this much delay in approval for therapies. Nor have I seen the goal post repeatedly moved over and over again by the FDA.
They screwed up approving the new Alzheimer's drug and now they are going to screw with every new drug application to avoid having egg on their face once again.
FYI, if anyone thinks the FDA loves the industry they govern, you are wrong. In 30 years it is obvious that the FDA has no love loss for pharma/biotech.
We need new leadership and better reviewer. Those who can review new drug applications in the time frame they assign to the companies.
I have never been more disappointed and frustrated with the FDA.

[San Marzano]

@arabian horses it's a tough job and likely a thankless job. From the regulators's perspective all companies want their new drug submission approved so being objective and honest and fair/non biased, tough. Getting competent people tough. Hopefully TG's application given an unbiased assessment and judged on merit.

[Crazinesscontinues]

My email to a lot of TG staff are bouncing back. Looks like Titanic is going down?

[Arabian Horses]

@Crazinesscontinues So they are expected to talk to you about a product not approved by the FDA which is a felony. You must be shorting TG!

[Crazinesscontinues]

@arabian horses No! I bought TG long time ago...sold at $30....
Have been watching them closely.

I was emailing TG folks I saw at a conference...all emails bouncing back.

Never liked this company. Investor calls were always strange....CEO would abruptly stop people from making some comments. Insider....printing of money was also awful.

interesting to see how TG went down!!

[LRNMO25]

The ODAC has now been scheduled for late Apr. FDA not in a real hurry here...Hope MS PDUFA goes smoother.

[DeVoVeD]

A conspiracy theorist would believe in outside (pharma competitor - Genentech) influence on the FDA with regards to TGTX. The MS drug is the key here. MS is a $10B+ pharma “industry.” Always follow the money.

[Robert1942]

First the FDA moves the goal posts then they issue more delays until maybe June. The FDA may not be incompetent, but they are certainly inefficient. Try running a cancer trial during a pandemic where immunocomprised individuals are at increased risk of dying from Covid 19. I do not think it should take 4 more months or possibly longer to review statistics

[jeybolt00]

I’m buying more today this news is not really negative other than from a timeline perspective and also expected. MS is the key I am willing to wait for that catalyst later this year. Good luck to all investors.

[Crazinesscontinues]

@jeybolt00 Good job Mike.
TG is doomed!