Accelerated, rather than full, approvals were prominent. As usual, cancer registrations predominated—including Amgen’s Lumakras, a first-in-class covalent targeter of KRAS in lung cancer. The other big news was the controversial go-ahead from the US Food and Drug Administration (FDA) for Biogen’s Alzheimer’s monoclonal antibody (mAb) Aduhelm, which later was given a narrower label by the agency; the approval prompted calls by the acting FDA head for a federal investigation into interactions between the drug developer and regulators. Less prominent, but also notable, was the approval of Truseltiq, a drug from the multi-asset play BridgeBio, providing validation for its business model. There were setbacks for two COVID-19 products, as well as the gene therapy timrepigene emparvovec for the eye disease choroideremia. FDA decisions coming up include new disease-modulating drugs in cervical cancer, myasthenia gravis and leukopenia.
Drug / company | Indication | Drug information |
|---|
Tisotumab vedotin / Seagen | Cervical cancer | 10/8/2021 FDA PDUFA date for this antibody–drug conjugate of a human IgG1κ mAb targeting human tissue factor conjugated to monomethyl auristatin E |
Plinabulin / BeyondSpring | Neutropenia, leukopenia | 11/30/2021 FDA PDUFA date for this small-molecule halimide derivative with selective immunomodulating microtubule-binding agent properties derived from marine Aspergillus sp. |
Palovarotene / Ipsen | Fibrodysplasia ossificans progressiva | 11/30/2021and 11/01/2021 FDA PDUFA and CHMP opinion dates for this selective small-molecule agonist of retinoic acid receptor-γ |
Efgartigimod / Argenx | Myasthenia gravis | 12/17/2021 FDA PDUFA date for this human IgG1 Fc fragment optimized to bind neonatal Fc receptor delivered using recombinant human hyaluronidase enzyme |
Balstilimab / Agenus | Cervical cancer | 12/16/2021 FDA PDUFA date for this fully human IgG4 mAb against programmed death ligand 1 (PD -1) |
- PDUFA, Prescription Drug User Fee Act; CHMP, Committee for Medicinal Products for Human Use (Europe). Source: BioMedTracker, a service of Sagient Research (http://www.biomedtracker.com)
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