US FDA approval tracker: April

Snippets

Three oncology drugs gained early approval last month, but their developers’ hardest task − launching during a pandemic − is yet to come. Immunomedics, which gained approval of Trodelvy in triple-negative breast cancer, insisted that it was all set for launch with virtual video conferencing and telesales in place. Elsewhere, Seattle Genetics said the past couple of months of virtual commercialisation with Adcetris and Padcev would help strategise the Tukysa launch in metastatic, Her2-positive breast cancer. Incyte too noted that it would build on past experience, in this case of selling Jakafi during the pandemic, when it comes to launching Pemazyre in cholangiocarcinoma. Neurocrine, on the other hand, delayed the launch of its add-on Parkinson’s treatment Ongentys, owing to both the pandemic and supply chain issues for partner Bial.

Notable first-time US approval decisions in April
Product Company 2026e WW total sales ($m) Outcome
Trodelvy (sacituzumab govitecan) Immunomedics 2,151 Approved (~1.5 months early) 
Reblozyl Bristol Myers Squibb/Acceleron 1,715 Approved
Tukysa (tucatinib) Seattle Genetics 950 Approved (4 months early)
Ongentys (opicapone) Neurocrine/Bial/Ono 344 Approved
Pemazyre (pemigatinib) Incyte 335 Approved (1 month early)
Jelmyto (UGN-101/mitomycin gel) Urogen 133 Approved
Koselugo (selumetinib) Astrazeneca 84 Approved
Trevyent United Therapeutics/Correvio 54 CRL
MenQuadfi Sanofi - Approved
Source: EvaluatePharma, Go or no go? Covid-19 upstages US regulatory decisions.

 

Supplementary and other notable approval decisions in April  
Product Company Indication (clinical trial) Outcome
Braftovi + Erbitux Pfizer BRAF V600E–mutated Colorectal cancer (Beacon CRC) Approved
Otezla Amgen Moderate to severe scalp psoriasis (Style) Approved
Imbruvica J&J Imbruvia plus rituximab for the
treatment of patients with CLL (E1912 study)
Approved
Keytruda Merck Every six-week dosing schedule Approved
Zejula  Glaxosmithkline First-line maintenance treatment for ovarian cancer regardless of BRCA mutational status (Prima) Approved
Source: EvaluatePharma, Go or no go? Covid-19 upstages US regulatory decisions.

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