The milestone payment relates to the reimbursement approval and commercial launch in Spain of FOTIVDA as a first line treatment
of adult patients with advanced renal cell carcinoma.
US-based Merck's anti-PD-1 therapy, Keytruda, has improved overall survival compared to standard of care as first line treatment
for patients with recurrent or metastatic head and neck cancer (HNSCC) in the pivotal phase three Keynote-048 trial, it was reported on Tuesday.
The first line treatment
for this subtype in current guidelines is steroids.
In the second appraisal the three other drugs are not recommended for use as a first line treatment
and neither Sutent or Nexavar have been approved as a second-line treatment for the disease.
"Sunitinib was not licensed by the Medicines Health Regulatory Agency as a first line treatment
until January this year - by this time we had received requests for its use as a second line treatment.
The traditional first line treatment
for otitis media (middle ear infections) is ten days of amoxicillin or trimethoprin-sulfamethoxazole (Septra or Bactrim).
Seladelpar is a drug candidate for PBC patients who are inadequate responders to ursodeoxycholic acid, the first line treatment
of PBC, or who are intolerant to ursodeoxycholic acid.
Pharmaceuticals company Roche (SIX:RO)(OTCQX:RHHBY) reported on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for its Premarket Approval (PMA) supplement for the cobas EGFR Mutation Test v2 to be used as a companion diagnostic test (CDx) for first line treatment
of patients diagnosed with metastatic NSCLC (non-small cell lung cancer).
The North-East and Cumbria Cancer Drug Approvals Group has agreed Sunitinib should be used, pending guidance from the National Institute of Health and Clinical Excellence (Nice), as a first line treatment
for patients with kidney cancer.
Together with the previously completed TIVO-1 trial of tivozanib in the first line treatment
of aRCC, TIVO-3 is designed to support regulatory approval of tivozanib in the U.S.
The product is intended as a first line treatment
for adult patients with advanced renal cell carcinoma.