Theratechnologies Inc T.TH

Over $400k annually for…

[scarlet1967]

“Tivdak’s wholesale acquisition cost is $5,885 per 40mg single dose vial, with patients’ individual costs determined by body weight and duration of therapy, a spokesperson said by email. The companies estimate an average WAC per patient per month of $34,000, before discounts or rebates.”

This ADC approved yesterday will gross estimated over $400k annually. 

 

Seagen - Seagen and Genmab Announce FDA Accelerated Approval for TIVDAK™ (tisotumab vedotin-tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer

[Wino115]

Another ADC is good news, especially as the BLA was filed in Feb, Accellerated App granted in April, and now approved in Sep. All on  phase 2 with 101 patients and an objective response of only 24% and  durability of response of 8 months in cervical cancer, but with a high percentage of safety issues many of which are on the serious side (50% for hemoglobin and lymphocyte decrease and 40

[SPCEO1]

I have seen some trials being described as 1b/2. Could TH's 1b turn into a 1b/2 trial?

[qwerty22]

Another variable to consider is the treatment landscape for metastatic cervical cancer. The limited drugs approved may have lowered the bar on this one. It definitely looks like a mixed bag of results. It would be interesting to see the very earliest data releases on this program to see whether you could discern an approvable dataset at that time. Another interesting number coming out of this

[qwerty22]

Just to follow up on that. Some of the indications thtx has picked for part 2 (I'm thinking r/r pancreatic cancer) have a very short list of approved drugs and some of those drugs have very horrible looking profiles from an efficacy perspective (my memory is there is one drug with a 10-15% ORR in pancreatic cancer that got approval). If they see activity in pancreatic cancer for example you

[Wino115]

Here's the earliest data releases on TIVDAK. They called their trial a Phase1/2 throughout and coming out of the Phase 1 they did a basket but most of the efficacy was seen in cervical and since it was unmet, that's probably where the FDA and CMO guided them for the Phase 2.  Although, I think the Phase 2 did enroll for a few other types, like the Phase 1b extension, but they just