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September 20, 2021September 16, 2021 – Takeda's ExkivityTM (mobocertinib) has received U.S. FDA approval to treat adults who have locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, and whose disease has progressed on or after platinum-based chemotherapy.
- This the is the first and only FDA-approved oral therapy specifically designed to target EGFR exon 20 insertion mutations. These rare mutations are associated with the development of lung cancer in non-smokers, and as well as with a poor response to conventional chemotherapy treatment.
- Recommended Exkivity dosing is 160mg (four 40mg capsules) taken by mouth once daily until disease progression or unacceptable toxicity occur. Capsules should be swallowed whole.
- Exkivity has launched at a wholesale acquisition cost (WAC) of $25,000 for a one-month supply.