If the FDA follows the advice of its Oncologic Drugs Advisory Committee (ODAC), both Keytruda and Tecentriq will remain on the U.S. market, for the time being, with accelerated approval as first-line treatments for certain patients with advanced or metastatic urothelial carcinoma. The committee voted 5-3 April 28 to recommend continuing accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) and 10-1 for maintaining the accelerated approval of the Roche Group’s Tecentriq (atezolizumab) until the final data come in from a confirmatory trial that’s expected to be completed next year.

In a virtual meeting fraught with technical difficulties, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 7-2 April 27 that the accelerated approval for Tecentriq (atezolizumab) in combination with nab-paclitaxel as a treatment for unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) in adults with PD-L1+ tumors should continue as additional trials are conducted or completed.

Being in a crowded space doesn’t bother recently installed Arch Oncology Inc. CEO Laurence Blumberg. As a matter of fact, he’s reassured by it. “There’s a lot of competition in CD47, that’s correct,” Blumberg told BioWorld. “But having been in industry for a long time, competition and the magnitude of that competition in pursuit of a target usually means there’s a good reason for that interest and that there’s compelling evidence it has utility.”

As part of a U.S. FDA evaluation of confirmatory trials for anti-PD-1/PD-L1 antibodies, the agency’s Oncologic Drugs Advisory Committee (ODAC) is being asked this week to consider whether three blockbuster biologics should continue to be available for certain cancer indications for which they received accelerated approval. At question is whether the data from the confirmatory trials for the Roche Group’s Tecentriq (atezolizumab), Merck & Co. Inc.’s Keytruda (pembrolizumab) and Bristol Myers Squibb Co.’s Opdivo (nivolumab) has proved sufficient benefit in particular indications and, if not, whether alternative or ongoing trials could do so.

Twenty years after the first, exclusively white human genomes were fully sequenced, science finds itself in the same position as the rest of society: with the uncomfortable realization that old inequalities are often morphing, rather than disappearing.

DUBLIN – Isotopen Technologien München (ITM) AG raised €90 million (US$108 million) in debt financing to complete phase III development of its lead radiopharmaceutical, solucin, in gastroenteropancreatic-neuroendocrine tumors and to take forward several more preclinical pipeline projects.

Another PD-1 antibody is about to hit the U.S. market, following the FDA’s accelerated approval of dostarlimab (TSR-042) from partners Anaptysbio Inc. and Glaxosmithkline plc. But dostarlimab, branded Jemperli, will be only one of two PD-1 drugs indicated for endometrial cancer, going up against Merck & Co. Inc.’s Keytruda (pembrolizumab).

HONG KONG – Qilu Pharmaceutical Ltd. has inked a deal for the global rights to Peptron Inc.’s antibody-drug conjugate (ADC) candidate PAb-001-ADC for the treatment of various cancers. Seoul, South Korea-based Peptron stands to receive an up-front payment of $3 million and $539 million in milestone payments, as well as royalties.