That deal will hoist its victory flag, this week -- as FDA's accelerated decision date arrives. I'll let BioSpace tell the story from here, as their rendition is very well thought out:
. . .By June 26, the FDA is expected to release its verdict on Merck and Daiichi Sankyo’s Biologics License Application (BLA), seeking approval for its investigational antibody-drug conjugate (ADC) patritumab deruxtecan to treat EGFR-mutated non-small cell lung cancer (NSCLC).
Designed using Daiichi Sankyo’s proprietary DXd technology, patritumab deruxtecan is an investigational ADC that targets the HER3 protein, which is highly expressed across a variety of solid tumors, including breast and lung cancer. The ADC carries a number of exatecan derivative topoisomerase I payloads, which can kill the targeted cancer cells.
Merck and Daiichi Sankyo’s BLA, which the FDA accepted and granted Priority Review in December 2023, is backed by data from the pivotal Phase II HERTHENA-Lung01 study, which demonstrated a 29.8% objective response rate in 225 patients with advanced or metastatic NSCLC that had progressed after prior treatments. . . .
Merck and Daiichi Sankyo entered into a global partnership in October 2023 to develop and commercialize three ADCs developed using Daiichi Sankyo’s DXd ADC platform. These assets include patritumab deruxtecan, as well as ifinatamab deruxtecan for small-cell lung cancer and raludotatug deruxtecan in ovarian cancer. . . .
Now you know -- onward, into the sunshine here -- also, into the week that Martin Shkreli's life long ban from all life sciences, and pharmaceuticals, industries (as well as the securities industries, earlier) became absolutely final. His twice extended deadline for cert. at the Supremes was missed last Friday night. His ban is final and now unappealable, any longer. See 'ya, loser. Out.
नमस्ते
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