Why generic lenalidomide is delayed: Celgene sued generic companies citing patent infringement. Now BMS has reached agreement with 3 companies limiting sales to <10% volume each— effectively prolonging Revlimid monopoly till 2026. Not good for patients. @DavidP4AD@matthewherper
The argument that new drugs go generic after 10-15 years & become inexpensive is not a reality in cancer. Patent life is prolonged by a variety of methods:
Lawsuits
Pay for delay
Volume limited agreements with generic companies
Introducing “me too” drugs as novel replacements
Correction: the terms of agreement with one of the companies (Dr. Reddy’s) is not known. But for two of the generic companies it is volume limited to less than 10% until 2026. fiercepharma.com/pharma/after-p…
FDA approval doesn’t necessarily mean standard of care.
Thread.
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For example FDA approved Dara VMP for frontline therapy in myeloma in 2018.
Literally no one used the regimen in the US.
Literally no one felt the regimen was standard of care in the US.
Before or after approval!
Why?
FDA adjudicates a sponsors submission on whether a given drug/regimen has met the burden of proving safety and efficacy.
Standard of care in clinical practice is a different standard: judgment of risk/benefit of available alternatives, and assessment of trial design/end points.
Cure is a simple word. But there is confusion when it comes to cancer. What cure is in cancer, and what we should aspire for?
When can we say that a given type of cancer is curable?
Thread
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There is a difference between when we can say a particular cancer is a curable type versus whether individual patients with a given cancer can be considered potentially cured.
They are not the same.
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To call a cancer curable we must be able to treat the cancer for a finite duration, stop all therapy, and know that a certain % of patients will never relapse
Early stage solid tumors, Hodgkin lymphoma, DLBCL, ALL, AML are curable. Real cure. The definition of curable cancer
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The 4 big myeloma randomized trials to watch out for @ASCO #ASCO24
1. Isa-VRd vs Isa-Rd newly diagnosed
2.Isa-VRd vs VRd (IMROZ)
3.DREAMM8 Bela-Pd vs Pd
4.Ven Dex vs Pom Dex (Canova)
See thread for why they are important.
1) The Triplet vs Quad trials with will define role of quads in elderly patients with newly diagnosed myeloma. They also provide frontline phase III data with Isatuximab— and a choice between Dara and Isa. For some patients Isa will be more cost effective. @Myeloma_Doc #ASCO24
2) Belantamab will make a comeback.
Corneal toxicity is low with reduced frequency dosing. The drug works very well. And in many patients with refractory myeloma belantamab may be safer and easier to do than bispecifics. We need options. #ASCO24
2/ Even though CART (cilta-cel) is approved for first relapse we are NOT including it in our main algorithm. Reserved only for special circumstances in this population. We have a long track record with standard triplets, and we are concerned about CART side effects.
3/ The current approach for second or higher relapse continues to define 3 specific types of Triple Class refractory. This makes it easier for clinicians to consider options.
To my followers who wonder what MOC is, and why many doctors are tweeting about it. Thread.
1) Maintenance of Certification (MOC) is a redundant requirement thrust on US physicians by a private organization. We resent it.
2) MOC is causing frustration and burnout. Over the years, ABIM certification and MOC have become entrenched and institutions and insurers require it and will not accept any other alternative.
I am advocating on behalf of my colleagues in the US for change. To end MOC.
3) MOC requires us to pay fees imposed on us by a private organization and take multiple choice question tests irrelevant to our practice.