GSK
Pharmaceutical R&D Manufacturer
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7Month17Day, a highly anticipated“Life and Death Vote”InFDAExpert Committee on Oncology Drugs (ODAC). The protagonist isGSKTheADCStar——Blenrep（belantamab mafodotin). Two years ago, it failed in the confirmatory trial and was withdrawn from the global market; two years later,GSK With“Combination Punch”The plan made a comeback, attempting to make it in the U.S. market.“Resurrection”. However,ODACGave a brutal answer with two veto votes:
Blenrep+TakedaVelcade+Dexamethasone:5Vote against,3Ticket Support
Blenrep+BMS Pomalyst+Dexamethasone:7Vote against,1Ticket Support
“Resurrection Race”Lost in the first round,GSKStock Price Fell in the Afternoon5.5%。
The Awkward Balance of Strong Efficacy and High Toxicity
DREAMM-7AndDREAMM-8Two itemsⅢThe efficacy figures given in the study are indeed impressive: whether used in combinationVelcadeStillPomalyst，BlenrepSignificantly ExtendedPFS。
However,FDAThe background document released before the meeting used two“High”Character Setting: High proportion of ocular toxicity, high frequency of dose adjustment. The incidence of keratopathy, vision loss, and even corneal ulcers made reviewers exclaim.“Unacceptable”。More challenging is that, in order to alleviate these toxicities, more than half of the patients have to reduce the dosage or delay the administration, which makes“Optimal Dose”This fundamental issue remains unresolved once again. As one committee member put it:“The data is very strong, and the toxicity is also very strong. We can't blindly approve the current dose.
Less than 5% of patients in the U.S., data "extrapolation" questioned
DREAMM-7And-8The proportion of American patients included is lower than5%`, which led some members to directly cast opposing votes.`——“How to evaluate the risk-benefit for the American population when there are hardly any Americans in the sample?”In the increasingly emphasized review of oncology drugs“Real-world Representativeness”At present, this shortcoming has been infinitely magnified. In other words,GSKMoving global data to the U.S. failed to prove that patients on this land could replicate the same benefits.
The Only Supporting Vote: The Voice of the Patient Representative
Amidst a chorus of opposition, the committeeJohn DeFlice——A Patient Representative——Cast the only vote in favor. In his view, the problem with the design itself was biased: compared to dosage and region, the more critical issue is“A New Accessible Therapy for an Incurable Malignant Tumor”. Public testimonies from the patient community also echo this point:BlenrepThough eye toxicity is troublesome, it can be managed through means such as eye drops and dose adjustments; however, the suffering caused by tumor progression has no alternative.“Ready-made medicine”Replaceable.
GSK's Next Step: Re-dosing, or Moving to Europe?
BlenrepNot the first setback.2020In the year, it was used as a single-agent fifth-line treatment.“Conditional”Listed, but in2022Withdrawn from the global market after a failed validation study years ago. Now making a comeback, only to be stuck again at“High toxicity, dosage unresolved”The old problem.GSKPreviously stated, predictedBlenrepSales peak can exceed30Billion pounds (approximately40Billion USD), and can now only hope that the joint solution approved by Europe and the UK will generate cash flow first.FDAThe final ruling will be in7Month23The result will be announced on the same day, but it is widely believed in the industry that it is difficult to reverse.ODACThe negative trend,GSKA more hardcore solution must be provided for dose optimization and supplementation of U.S. data.
Implications for the Chinese Market: How Narrow is the ADC Safety Window?
BlenrepThe dilemma also reflects China's rapid advancement inBCMA ADCTrack Sounds the Alarm: High ActivitypayloadWhile bringing high efficacy, it often comes with a series of chain reactions such as dose limitations, complex toxicity management, and difficulties in extrapolating to broader populations. Produced in ChinaBCMA ADCIf you want to avoid“Limited Upon Listing”The embarrassment lies in the need to solidify the safety window, population representativeness, and companion diagnostics early on.
DistanceFDAThe final ruling is only days away,BlenrepWhether it is possible to“Toxicity High Wall”Carve out a path to survival? The answer will be revealed soon.