September 16, 2021

Takeda’s Exkivity™ (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 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 Capsules should be swallowed whole.
  • Exkivity has launched at a wholesale acquisition cost (WAC) of $25,000 for a one-month supply.
September 21, 2021

FDA Approves Ophthalmic Biosimilar Byooviz

Read More
September 17, 2021

Cabometyx Now Indicated to Treat Common Form of Thyroid Cancer

Read More
September 16, 2021

New Lung Cancer Drug Exkivity Receives FDA Approval

Read More
September 16, 2021

Two-Drug Therapy Authorized for COVID-19 Post-Exposure Prevention

Read More