
US FDA approval tracker: April 2020
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. |