Paid

In Brief

FDA seeks $8.4B to further investments in public health programs, including $20M for Cancer Moonshot efforts

FDA is requesting a total budget of $8.4 billion as part of the president’s fiscal year 2023 budget—a nearly 34% ($2.1 billion) increase over the agency’s FY 2022 appropriated funding level—for investments in critical public health modernization, core food safety and medical product safety programs, and other public health infrastructure. 
Clinical Roundup

SKYSCRAPER-02, the first randomized study of tiragolumab in ES-SCLC, did not meet co-primary endpoint of PFS, Genentech says

Genentech announced that the phase III SKYSCRAPER-02 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) and chemotherapy (carboplatin and etoposide) as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), did not meet its co-primary endpoint of progression-free survival. 
Drugs & Targets

EU CHMP adopts positive opinion for Keytruda plus chemo ± bevacizumab in persistent, recurrent, or metastatic cervical cancer expressing PD-L1 (CPS ≥1)

The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with chemotherapy and with or without bevacizumab, for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumors express PD-L1 (CPS ≥1).
Drugs & Targets

EU CHMP adopts positive opinion for Cabometyx in radioactive iodine-refractory differentiated thyroid cancer

The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Cabometyx (cabozantinib) as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma, refractory or not eligible to radioactive iodine, who have progressed during or after prior systemic therapy.