Pipeline News and Updates
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Regulatory Update
The FDA granted Fast Track status to ADI-001 for the treatment of relapsed or refractory B-cell Non-Hodgkin’s lymphoma. PLOS One has retracted five articles describing research evaluating simufilam for the treatment of Alzheimer’s disease (AD). According to the New York Times (NYT), the studies were retracted due to questions regarding the validity of the results. NYT interviewed nine AD expert and all expressed concern over the design of the trials and the accuracy of the results. The FDA accepted the NDA for daprodustat for the treatment of anemia of chronic kidney disease (CKD) and assigned a PDUFA date for 2/1/2023 The FDA accepted the resubmitted BLA for daxibotulinumtoxinA for the treatment of moderate to severe glabellar lines and set a PDUFA date for 9/8/2022. The FDA accepted the BLA for tremelimumab, given with durvalumab, for the treatment of unresectable hepatocellular carcinoma suggesting a PDUFA date for 10/25/2022. CHMP recommended approval of mosunetuzumab for the treatment of relapsed or refractory follicular lymphoma after failure of at least two prior systemic therapies. Announced Research Updates Mirati announced results from a Phase I/II trial, evaluating the combination of sitravatinib plus nivolumab in the treatment of advanced clear cell renal cell cancer. Published Research Updates Results were published from a Phase II trial evaluating the outcome from adding cilofexor and/or firsocostat to semaglutide in patients with NASH. The Phase III, Chinese RATIONALE 302 trial results were published describing a comparison of treatment with tislelizumab to investigator’s choice of paclitaxel, docetaxel or irinotecan (in the treatment of advanced or metastatic esophageal squamous cell carcinoma. Results from a Phase II trial were published evaluating pixantrone in the treatment of refractory HER2-negative metastatic breast cancer. The SURPASS-3 CGM sub-study results were published, comparing tirzepatide to insulin degludec, for maintainingblood glucose in the target range of 71-140 mg/dL in patients with type 2 diabetes. Regulatory Update
TG Therapeutics voluntarily withdrew the pending BLA/sNDA for the combination of ublituximab and umbralisib for the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma due to lower overall survival compared to obinutuzumab plus chlorambucil in the UNITY-CLL trial. TG Therapeutics also voluntarily withdrew umbralisib (Ukoniq) from the market. Umbralisib had been approved in February 2021, under an accelerated approval, for the treatment of relapsed or refractory marginal zone lymphoma or refractory follicular lymphoma. The FDA designated celiprolol a Breakthrough Therapy for the treatment of vascular Ehlers Danlos Syndrome. Coeptis Therapeutics bought marketing and development rights for entolimod from Statera Biopharma. Announced Research Updates Nektar and BMS announced results from the PIVOT 09 and PIVOT 10 trials, along with a decision on future development of the combination. Published Research Updates ICER released a draft review of betibeglogene autotemcel for the treatment of beta thalassemia. Results were published for a Phase I/II trial, evaluating rilzabrutinib in the treatment of patients with immune thrombocytopenia (ITP). Regulatory Update
The FDA accepted the resubmitted BLA for eflapegrastim for the management of chemotherapy-induced neutropenia and set a PDUFA date for 9/9/2022. The FDA removed the hold on trials evaluating magrolimab and azacitidine, but left the hold on the magrolimab monotherapy trials in place. Saniona paused two Phase IIb trials evaluating tesofensine and metoprolol in the treatment of hypothalamic obesity and Prader-Willi syndrome in order to reduce operating expenses. Reata resubmitted an NDA for omaveloxolone for the treatment of Friedreich’s ataxia. Announced Research Updates Coherus BioSciences and Junshi Biosciences announced results from the JUPITER-02 trial, which evaluated the addition of toripalimab to gemcitabine plus cisplatin in the treatment of recurrent or metastatic nasopharyngeal carcinoma. Merck announced results from the cervical cancer cohort of the KEYVIBE trial, which was evaluating the combination of vibostolimab plus pembrolizumab. Lilly announced ADhere trial results, which evaluated adding lebrikizumab to topical corticosteroids in the treatment moderate-to-severe atopic dermatitis. Published Research Updates Two Phase III trials evaluating an investigational oral drug to an established parenteral drug were published. The ASCEND-ID trial compared oral daprodustat to parenteral darbepoetin alfa on maintenance of hemoglobin levels in CKD patients receiving incident dialysis. The ADAPT-PO trial compared oral tebipenem to intravenous ertapenem in the treatment of complicated urinary tract infection or acute pyelonephritis. Last week we added 15 new drugs to the knowledgebase:
Regulatory Update
The FDA rejected vadadustat due to cardiovascular, thromboembolic and hepatotoxicity safety concerns and recommended new trials to assess safety. The FDA extended the PDUFA date for vutrisiran by three months to 7/14/2022, for the treatment of transthyretin-mediated (ATTR) amyloidosis, to allow time to review information on a new packaging and labeling facility. The FDA extended the PDUFA date for ublituximab for the treatment of CLL and small lymphocytic lymphoma (SLL) by three months to allow additional time to review new data. The new PDUFA date is 6/25/2022. The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 6 to 4 to recommend the FDA reject AMX0035 or the treatment of ALS and recommended an additional trial to evaluate efficacy. The FDA accepted the NDA for futibatinib for the treatment of locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions and set a PDUFA date for 9/30/2022. ImmunoGen submitted a BLA for mirvetuximab soravtansine for the treatment of folate receptor alpha (FRα)-high platinum-resistant ovarian cancer that has been previously treated with one to three prior systemic treatments. The FDA placed a partial hold on leronlimab HIV trials and a full hold on leronlimab COVID-19 trials in the United States. At the same time, CytoDyn decided to place a hold on its leronlimab COVID-19 Brazilian trial pending review of two cardiac events by the data safety monitoring board. Announced Research Updates Boehringer Ingelheim announced 12-week data for the spesolimab Effisayil 1 trial. Roche announced from the SKYSCRAPER-02 trial, evaluating the addition of tiragolumab to atezolizumab, carboplatin, and etoposide in patients with extensive-stage small cell lung cancer. Cytokinetics announced results from cohort III of the REDWOOD-HCM trial, evaluating aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy. BMS announced results for the VALOR-HCM trial evaluating the effect of mavacamten on the need for septal reduction therapy in patients with symptomatic obstructive hypertrophic cardiomyopathy. BMS also announced long-term-extension results from the EXPLORER-LTE trial, evaluating mavacamten in the treatment of patients with NYHA Class II or III obstructive hypertrophic cardiomyopathy. Published Research Updates H. pylori eradication with vonoprazan compared to lansoprazole results were published. Harvard researchers discuss the estimated cost effective prices for aducanumab and donanemab in a new analysis. A comparison of anetumab ravtansine to vinorelbine in the treatment of unresectable locally advanced or metastatic disease overexpressing mesothelin was published. Results were published for the GOAL trial evaluating pixantrone plus obinutuzumab in the treatment of diffuse large B-cell lymphoma. The efficacy of CTP-543 in the treatment of moderate to severe alopecia areata was published Results were published for the ROCKIES trial, comparing oral roxadustat to parenteral epoetin alfa in patients with dialysis-dependent CKD. |
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March 2023
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