Genmab — Maj 2020

[E_L]

Turning now out or pipeline on the horizon with a clinical trial readout is Tisotumab Vedotin or TV which we are developing in collaboration with Genmab.

[E_L]

We’re conducting a pivotal Phase 2 single-arm simulation trial in women with recurrent or metastatic cervical cancer where there is no standard of care and outcomes are poor. We expect to report top line results late this quarter or into the third quarter.

[E_L]

Q: it seems like the tisotumab vedotin readout maybe got pushed back a little bit, given this trial was fully enrolled.

[E_L]

A: The most important thing with our data with TV is that this is potentially registerable. And we need to follow the data and follow the duration of the data and work with a third-party that puts these type of blinded data together and before we can present this and reveal the data.

[E_L]

So that’s something that’s ongoing. We’re working hard at. If they may very well come this quarter, okay, and we’re working toward trying to make that happen. We just put out that it may slip a little bit into the third quarter, just in case it does but we’re working hard to get this done in the soonest time frame possible. So I wouldn’t read too much into it. And you will hear about it soon.

[E_L]

from Amgen on KYPROLIS:

[E_L]

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15, 2020 for the supplemental New Drug Application (sNDA) to expand the Prescribing Information to include KYPROLIS in combination with dexamethasone and DARZALEX (daratumumab) for patients with relapsed or refractory multiple myeloma based on data from the Phase 3 CANDOR study.

[E_L]

In February, a variation to the marketing authorization application was submitted to the European Medicines Agency to expand the indication for Kyprolis in relapsed multiple myeloma based on data from the Phase 3 CANDOR study.

[Sukkeralf]

Nice work E L ????

[Sukkeralf]

?????? Was a smiley

[Bulder]

very very nice

[Bulder]

[Sukkeralf]

[Bulder]

Så får vi ofa-godkendelse, TV-data og partneraftale lige oven i hinanden

[E_L]

yes, could be a great summer, for Genmab. (if markets don't crash again for a double bottom or something...) Jan will probably be in a good mood next week

[lahn1]

Exciting time ahead, but wouldn't mind a double bottom

[bibob]

C
ould Dara sc possibly be used off label allready now. ???

[E_L]

not sure in europe, but in US there is Pre-Approval Access via https://clinicaltrials.gov/ct2/show/NCT04264884?term=genmab+OR+daratumumab+OR+darzalex+OR+ofatumumab+OR+Teprotumumab+OR+Tisotumab+OR+camidanlumab+OR+Enapotamab+OR+ADCT-301+OR+duobody&lupd_s=02%2F11%2F2020&draw=2

[E_L]

if you have a doctor that is a bit creative, i would imagine he could get his patients on, specially in covid time. But i am not sure if it is used

[bibob]

Thx E L. - That could spare some time for the Doctors. And time is ( big ) money.