Genmab — April 2020

[E_L]

but seriously, FDA apparantly not really delayed very
much, still approving some drugs rather fast

[DevOp]

Cross fingers for tomorrow or Friday next week

[E_L]

Blood: A prospective phase 2 trial of daratumumab in patients with previously treated systemic light-chain amyloidosis https://ashpublications.org/blood/article-abstract/135/18/1531/452572/A-prospective-phase-2-trial-of-daratumumab-in

[E_L]

Safety, tolerability, and response rates of daratumumab in relapsed AL amyloidosis: results of a phase 2 study https://ashpublications.org/blood/article-abstract/135/18/1541/440750/Safety-tolerability-and-response-rates-of

[bibob]

I like this line. https://ashpublications.org/blood/article-abstract/135/18/1509/454455/AL-patients-don-t-dare-go-without-dara?redirectedFrom=fulltext

[E_L]

JNJ should use that in their marketing lol

[E_L]

YES!

[E_L]

SC EUROPE

[E_L]

The CHMP recommended the addition of a new pharmaceutical form (solution for injection) associated with a new strength and a new route of administration (subcutaneous injection into the abdomen) for Darzalex (daratumumab).

[E_L]

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020 | European Medicines Agency (EMA)

European Medicines Agency (EMA) (www.ema.europa.eu)

[GeorgeBest]

YES

[JørgenVarnæs]

Let the penetration begin

[Bulder]

Following a CHMP opinion the European Commission takes usually its
decision, a legally binding authorisation, after 67 days.

[lahn1]

9th place ????for Darzalex revenues in 2026 ? https://www.evaluate.com/vantage/articles/data-insights/long-term-forecasts-confirm-keytrudas-dominance

[lahn1]

Bare en spøjs statistik

[Bulder]

Nu ligger førerfeltet jo ret tæt samlet. Så en plads 6-9 er ret sandsynlig.

[Mcjean]

Mon det smitter af på Halo?

[Mcjean]

Kan ikke lige ses på kursen.

[GeorgeBest]

Now from Genmab https://ir.genmab.com/news-releases/news-release-details/chmp-issues-positive-opinion-recommending-subcutaneous

[E_L]

The CHMP’s Positive Opinion for the subcutaneous formulation of daratumumab applies to all currently approved daratumumab indications in frontline and relapsed / refractory multiple myeloma settings.