It’s been a decade since Sandoz Inc. launched Zarxio, referencing Amgen Inc.’s Neupogen (filgrastim), as the first biosimilar in the U.S. Zarxio was expected to be the beginning of a biosimilar boom that would deliver big savings by finally providing direct competition for costly biologics. Neither the pipeline nor the uptake of biosimilars has lived up to expectations, as only 6% of the 313 biologics approved by the FDA’s CDER have been targeted by biosimilars and fewer than 5% are actually competing with the follow-ons.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) met for what chairperson Christopher Lieu called, at the end, “an incredibly long day” to decide whether approval of immune checkpoint inhibitors should be restricted in accordance with expression levels of PD-L1.
Immune checkpoint inhibitors (ICIs), such as anti-CTLA-4 antibodies, are widely used in cancer immunotherapy. CTLA-4 blockers such as Yervoy (ipilimumab, Bristol Myers Squibb Co.) stimulate antitumoral immune responses, but may also induce toxicity, such as colitis, a common immune-related adverse event that can lead to treatment discontinuation.
Three giants have produced new phase III study data for their already approved, big name therapies. Two were positive and the third was stopped for futility.
It’s another setback for Jounce Therapeutics Inc. Top-line data from the phase II Select study of vopratelimab, the company’s lead candidate, combined with pimivalimab vs. pimivalimab alone in 69 patients missed its primary endpoint of mean tumor change when averaged over nine and 18 weeks. The clinical trial participants were immunotherapy naïve, immunotherapy TISvopra biomarker-selected, second-line non-small-cell lung cancer (NSCLC) patients.
Shanghai Henlius Biotech Inc. signed an exclusive licensing deal with Organon LLC under which Organon will in-license rights for two of Henlius’ internally developed biosimilar candidates for global commercialization, excluding China, Hong Kong, Macau and Taiwan.
In the final part of its three-day meeting on accelerated approvals granted to anti-PD-1/PD-L1 antibodies, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously to continue the accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) as a therapy for patients with advanced hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (Nexavar, Bayer AG).
DUBLIN – The EMA’s Committee for Medicinal Products for Human Use (CHMP) diverged from the FDA on a key decision at its monthly meeting, which concluded Feb. 28. It refused to back an application from Eli Lilly and Co. for a line extension to its migraine prevention drug, Emgality (galcanezumab), which would have authorized the drug for preventing attacks during an episode of cluster headaches.
Cytomx Therapeutics Inc. CEO Sean McCarthy said earlier this month that the firm was “not ready to guide on specific response rates” that the company hopes for in the phase II study with anti-PD-L1 Probody CX-072 in combination with ipilimumab, or ipi (Yervoy, Bristol-Myers Squibb Co.) in patients with relapsed refractory melanoma.
