TG Therapeutics Inc (TGTX)

[stockguard]

AbbVie $ABBV could be weighing on $TGTX of late not to mention $VSTM
Verastem, Inc. also but still like $TGTX even more in the single digits as it has a good pipeline.....

Your Cancer Highlight: AbbVie Quietly Aims For A New Best-In-Class Approval In CLL
Sep. 18, 2018 8:00 AM ET|18 comments | About: AbbVie Inc. (ABBV), Includes: JNJ, RHHBF
Zach Hartman
Zach Hartman
Biotech, healthcare, Deep Value, contrarian
Invest Against Cancer
Summary
AbbVie and partner Janssen quietly announced an important submission.

The implications for CLL management are clear, and they signal a tighter weaving of one of their main drugs into the standard of care.

It's also a signal that we should pay attention to ASH this year for CLL.

Please note that I am affiliated with Avisol Capital Partners and their Total Pharma Tracker service. They have also covered the companies in this article in their writings, and I wanted to make readers aware of the potential for overlapping coverage.

Treatment of chronic lymphocytic leukemia (CLL) has come a very long way in just a few years, with the introduction of an array of new therapeutic options. Arguably, the most notable of these new options would be the emergent small molecule targeted therapies, particularly the Bruton's tyrosine kinase inhibitor ibrutinib and the Bcl-2 inhibitor venetoclax, both now owned by AbbVie (ABBV).

Specifically, ibrutinib has made a meteoric impact on the management of CLL, offering one of the first chances we've had for patients with high-risk disease features, along with the opportunity to replace chemotherapy for patients who are frail.

Needless to say, ABBV and their partner Johnson and Johnson (JNJ) have been working diligently to get ibrutinib weaved throughout the entire continuum of care for CLL, wherever it may fit. Thus, ibrutinib is now approved in the following indications:

Monotherapy treatment in CLL
Monotherapy treatment in CLL, specifically for patients with 17p deletion (a high-risk disease feature that is associated with poor responses to traditional therapy)
These approvals can restrict the use of ibrutinib to those patients who do not have aggressive disease (and hence no need for aggressive, multiagent therapy), for those who relapsed on chemotherapy, or for those who are not suitable candidates for chemotherapy (either due to high-risk disease features or old age/comrbidities).

As such, ABBV and JNJ have turned a lot of their attention toward exploring ibrutinib as part of different combinations, particularly with the goal of substituting chemotherapy for ibrutinib to arrive at a less toxic, more effective treatment regimen.

The news
Although it was not announced, ABBV's partner Janssen (of Johnson & Johnson) divulged during its Q3 business update that the first-line combo of ibrutinib and obinutuzumab had been submitted to the FDA for approval.

Therefore, it's likely that we're going to see some kind of news about the acceptance of this application. I'm not sure if it could get priority review, but this application sets a timeline for approval sometime in 2019.

Interestingly, the company also divulged its intentions to submit applications for approval in other indications, including in combination with rituximab for first-line therapy, as well as used as monotherapy in patients with higher-risk early-stage disease (where they would normally be managed by "watch and wait").

Looking forward
The application for approval was supported by findings from the iLLUMINATE study, a phase 3 trial comparing chlorambucil-obinutuzumab to ibrutinib-obinutuzumab for patients with CLL who had no prior exposure to therapy. We know from an announcement from JNJ and ABBV from earlier this year that iLLUMINATE met its primary endpoint of improved progression-free survival.

We have yet to see the full results of this study, but I expect they'll be coming at this year's ASH meeting. Even so, it's difficult to imagine that ABBV and JNJ will fail to get this approval, given the fact that the combination improved PFS, making it another opportunity to land an effective "chemotherapy-free" treatment regimen into the treatment landscape.

Moreover, it helps to build Roche's (OTCQX:RHHBF) credibility in an era where biosimilars will start to eat into rituximab sales. We could very well end up seeing a new standard of care emerge for those patients who are not suitable recipients of chemotherapy. Without a doubt, it would mean a continued domination of the CLL treatment space on the part of ABBV and JNJ.

While it wouldn't likely supplant chemoimmunotherapy for healthier, younger patients (under the age of 65 years), ibrutinib-obinutuzumab could well become a major contender for older patients. Considering CLL is a cancer particularly of old age (median age of diagnosis 72 years), this is no small thing, and currently chlorambucil-obinutuzumab is a major treatment option in this patient population, with a Category 1 recommendation from the NCCN.

Overall, this submission and subsequent approval (assuming it goes through) could very well be a game changer in the space, and discerning investors definitely need to keep an eye out for a formal presentation of the iLLUMINATE study later this year.

This quiet news is a definite signal that ABBV continues to build major inroads across the treatment landscape for CLL, and when it comes to replacing their aging blockbusters, this may be one of their major paths forward.

Thank you for taking some time out of your day to read this article! If you liked what you see, I hope you'll consider becoming a follower of mine on Seeking Alpha, as this will allow you to get real-time notifications when new articles of mine go live. Also, I want to let you know that I am a regular contributor to the Total Pharma Tracker, a marketplace service run by Avisol Capital Partners. If you want to join our conversations about biotech stocks, consider taking part in a free two-week trial today!

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. Please be aware of the risks associated with these stocks.

https://seekingalpha.com/article/4206839-cancer-highlight-abbvie-quietly-aims-new-best-class-approval-cll