The U.S. FDA’s Oncologic Drugs Advisory Committee meets April 28 to discuss the future of Astrazeneca plc and Merck & Co. Inc.’s supplemental NDA for Lynparza (olaparib) for an expanded label to treat prostate cancer. It has a few bones to pick. The FDA said it is concerned that the efficacy and safety have not been demonstrated outside of the small population of patients with tumor BRCA mutations and that the addition of olaparib to abiraterone may cause harm in patients who are definitively negative for tumor BRCA mutations.
Combining the personalized cancer vaccine mRNA-4157 (V-940, Moderna Inc.) with Keytruda (pembrolizumab, Merck & Co. Inc.) significantly extended recurrence-free survival in patients with stage III/IV resected high-risk melanoma in the randomized phase II KEYNOTE-942/mRNA-4157-P201 trial. Compared to Keytruda alone, adding the vaccine cut the risk of recurrence or death by 44% 18 months after treatment, lead investigator Jeffrey Weber reported at the opening clinical trials plenary of the 2023 annual meeting of the American Association for Cancer Research (AACR).
As Merck & Co. Inc.’s whopper proposal to take over Prometheus Biosciences Inc. for $10.8 billion faded from the ever-churning headlines, officials of the pharma heavyweight set about answering questions with regard to plans for the newly gained PRA-023, a humanized monoclonal antibody that targets tumor necrosis factor-like ligand 1A (TL1A).
As country after country downshifts out of pandemic mode, the need for affordable COVID-19 therapies continues, especially in middle-income countries that are not included in current voluntary licensing arrangements. To meet that need, the WHO is calling on manufacturers of those drugs to extend the geographic scope of their licensing agreements to allow competition and price reductions.
As country after country downshifts out of pandemic mode, the need for affordable COVID-19 therapies continues, especially in middle-income countries that are not included in current voluntary licensing arrangements. To meet that need, the World Health Organization (WHO) is calling on manufacturers of those drugs to extend the geographic scope of their licensing agreements to allow competition and price reductions so the treatments can be used where they’re needed most.
In the string of successes and frustrations generated by their five-year collaboration, Merck & Co. Inc. and Eisai Inc. can now add a few more frustrations. The companies are discontinuing the phase III LEAP-003 study of Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for first-line treatment of unresectable or metastatic melanoma because it did not improve overall survival (OS) vs. Keytruda as a monotherapy. Also, the phase III LEAP-017 trial evaluating the combination in unresectable and metastatic colorectal cancer did not meet its primary endpoint of OS.
In the string of successes and frustrations generated by their five-year collaboration, Merck & Co. Inc. and Eisai Inc. can now add a few more frustrations. The companies are discontinuing the phase III LEAP-003 study of Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for first-line treatment of unresectable or metastatic melanoma because it did not improve overall survival (OS) vs. Keytruda as a monotherapy. Also, the phase III LEAP-017 trial evaluating the combination in unresectable and metastatic colorectal cancer did not meet its primary endpoint of OS.
Merck & Co. Inc. has seen promise in Proxygen GmbH’s molecular glue degrader technology, agreeing to pay the drug discovery company up to $2.55 billion if specified research, development and commercial milestones are met.
As Seagen Inc. preps for a merger, the U.S. FDA awarded accelerated approval to the company’s big-selling Padcev (enfortumab vedotin). The approval is for a combination therapy with Merck & Co. Inc.’s Keytruda (pembrolizumab) as a first-line treatment for adults with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy.
During the first round of discussion at its two-day hearing on a World Trade Organization proposal to expand the intellectual property (IP) waiver from COVID-19 vaccines to diagnostics and therapies, the U.S. International Trade Commission (USITC) got an earful from both sides of the debate.
