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The agency approved the new indication based on data showing that the drug improved survival in patients compared to chemotherapy.
The agency approved the drug based on a study that showed an 88 percent response rate in young patients with ALK-positive anaplastic large cell lymphoma.
Drugmakers discussed advancing autologous CAR T-cell therapeutic programs, and several diagnostic firms detailed their efforts in precision oncology.
Verzenio, Ibrance, Rubraca, and bintrafusp alfa are some of the precision oncology products companies provided updates on during the conference.
On the first day, Amgen detailed the rapid advancement of its KRAS inhibitor and Tempus unveiled an AI device to help oncologists deliver precision oncology.
Although the pandemic may have been at the forefront of readers' minds, they remained interested in the latest advances and controversies in precision oncology.
The submission follows recently presented study data showing that the vast majority of patients on ciltacabtagene autoleucel responded to the therapy.
The agency made its decision based on data showing adjuvant Tagrisso decreased the risk of cancer recurrence or death by 80 percent compared to placebo.
If approved, the drug would be the first targeted therapy available to treat patients with NSCLC harboring KRAS G12C mutations.
The agency approved the drug based on data from the SOPHIA trial, which showed Margenza improved progression-free survival over Herceptin.