Theratechnologies Inc T.TH

RE:RE:FDA approved Gilead’s AD

[qwerty22]

I think it's worth drilling down on that data just to see where that value comes from. I'm no expert on this so assume some of it might be wrong.

https://www.gilead.com/news-and-press/press-room/press-releases/2021/4/fda-approves-trodelvy-the-first-treatment-for-metastatic-triplenegative-breast-cancer-shown-to-improve-progressionfree-survival-and-overall-surviv

The most clinically meaningful data in cancer studies is overall survival (OS), typically this requires longer and larger trials. Overall response rate (ORR) and PFS are both considered surrogates. If you think of NASH as a comparison, ORR and PFS is like biopsy data and OS is like the long term liver and CVD outcomes. Drugs can get approved on ORR and PFS but it is contingent on further studies to prove benefit in OS. A couple of cancer drugs just had their approval removed for not doing these follow on trials. It is quite common that PFS doesn't eventually lead to clinically meaningful OS. So a drug chasing approval via PFS might be valued less than a drug approved on OS.

So Trodelvy here got a FULL approval because their larger trial had OS data, it was tested against a chemo arm and it extended OS from 6.9 months to 11.8 months. All those details not only lead to a better approval than is often the case with drug with only ORR and PFS but it probably means the drug has a better impact in the clinic from the get go, basically doctors (and patients) care most about OS (with a good toxicity profile). I think if you where trying to use this deal as a comparator of what thtx's program might be worth you'd need to take these things into consideration.

We'll have to see how THTX's clinical program develops but if they chase the ORR/PFS fast track approach then you are right these numbers look like the numbers to match or beat in tnbc.

Wino115 wrote: This is the Immunomedics drug they bought in the $21bil deal. I think this is also why that KOL said a 3L/4L TNBC drug with a 20-30% response rate and 2 months of PF survival is a huge improvement.  That seems to be the bar to meet or exceed with TH1902 for the TNBC indication.
 

scarlet1967 wrote: The drug can cause severe neutropenia yet it got approved due to lukewarm results, now they want to go global. It shows a drug used as a last line of defence can get approved even with serious adverse effects and..,,

“Today’s approval is the culmination of a multi-year development program and validates the clinical benefit of this important treatment in metastatic TNBC,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Building upon this milestone, we are committed to advancing Trodelvy with worldwide regulatory authorities so that, pending their decision, Trodelvy may become available to many more people around the world who are facing this difficult-to-treat cancer.”

 

https://www.gilead.com/news-and-press/press-room/press-releases/2021/4/fda-approves-trodelvy-the-first-treatment-for-metastatic-triplenegative-breast-cancer-shown-to-improve-progressionfree-survival-and-overall-surviv

 

Trodelvy also may cause serious side effects, including:

• Severe neutropenia: Neutropenia means you have abnormally low levels of neutrophils, a type of white blood cell. People with neutropenia have a much higher risk of getting serious infections. Your doctor will monitor your neutrophil counts while you are being treated with Trodelvy. If you develop neutropenia, you may be treated with a granulocyte-colony stimulating factor medicine such as Neupogen (chemical name: filgrastim), Neulasta (chemical name: pegfilgrastim), or Zarxio (chemical name: filgrastim-sndz).
• Severe diarrhea: Severe diarrhea can cause dehydration, low blood pressure, and severe kidney problems. Tell your doctor about any diarrhea you have so it can be treated right away.

 

Trodelvy (sacituzumab govitecan): Side Effects, How it Works, and More