Genmab — Maj 2020
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Hvornår var godkendelsen ventet?
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Iflg Bulder kommer godkendelse i løbet af 67 dage (se i går kl. 20:40)
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Den havde jeg overset. Tak GB og Pensionisten.
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Mateos. “The daratumumab subcutaneous formulation has the potential to transform the treatment experience for patients and physicians as it reduces time in the chair from hours to minutes, and, because it is administered as a fixed dose from the first treatment, it reduces preparation time and chances of error by eliminating the need for dose calculations.” https://www.businesswire.com/news/home/20200430005934/en/CHMP-Grants-Positive-Opinion-DARZALEX
▼-daratumumab-Subcutaneous -
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SGEN - Tisotumab Vedotin innovaTV 204 Pivotal Trial Topline Results: Seattle Genetics and Genmab expect to report topline data late in the second or into the third quarter of 2020 for the innovaTV 204 pivotal trial of tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment.
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same from Seattle Genetics' Q1 2020 Results - Earnings Call Transcript https://seekingalpha.com/article/4341838-seattle-genetics-sgen-ceo-clay-siegall-on-q1-2020-results-earnings-call-transcript?part=single
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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.
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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.
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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.
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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.
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