Even though IMpassion132 is enrolling a different population and has a different chemotherapy backbone, it could confirm atezolizumab’s benefit for patients with advanced triple-negative breast cancer whose tumors express PD-L1, agency says ahead of advisory committee meeting on accelerated approval indications with failed confirmatory trials.
An ongoing Phase III trial of Genentech, Inc. 's Tecentriq (atezolizumab) in patients who experienced early recurrence of triple-negative breast cancer after prior therapy could provide a pathway to confirming the PD-L1 inhibitor’s benefit in first-line TNBC, a current accelerated approval indication facing the threat of withdrawal.
On 27 April, the Food and Drug Administration’s Oncologic Drugs Advisory Committee will kick off three days of meetings on...
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
