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On 27 January 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Breyanzi, intended for the treatment of adults with relapsed or refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after at least two previous lines of treatments. The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG. Lisocabtagene maraleucel was approved for medical use in the European Union in April 2022. Names
Lisocabtagene maraleucel is the international nonproprietary name (INN). References
External links
"Lisocabtagene maraleucel". NCI Drug Dictionary. National Cancer Institute. Clinical trial number NCT02631044 for "Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)" at ClinicalTrials.gov
Manali Kamdar, MD, MBBS, an Associate Professor at the University of Colorado Denver gives a video interview entitled Lisocabtagene Maraleucel FDA Approved For Large B-cell Lymphoma - https://oncologytube.com/video/41258
Lincomycin is a lincosamide antibiotic that comes from the actinomycete Streptomyces lincolnensis. A related compound, clindamycin, is derived from lincomycin by using thionyl chloride to replace the 7-hydroxy group with a chlorine atom with inversion of chirality. It was released for medical use in September 1964. Uses
Although similar in antibacterial spectrum and mechanism of action to macrolides, lincomycin is also effective against other organisms including actinomycetes and some species of Mycoplasma and Plasmodium.However, because of its adverse effects and toxicity, it is rarely used today and reserved for patients allergic to penicillin or where bacteria have developed resistance. Clinical pharmacology
Intramuscular administration of a single dose of 600 mg of Lincomycin produces average peak serum levels of 11.6 µg/mL at 60 min, and maintains therapeutic levels for 17 h to 20 h, for most susceptible gram-positive organisms. Urinary excretion after this dose ranges from 1.8% to 24.8% (mean: 17.3%). A two-hour intravenous infusion of 600 mg of Lincomycin achieves average peak serum levels of 15.9 µg/mL and yields therapeutic levels for 14 h for most susceptible gram-positive organisms. Urinary excretion ranges from 4.9% to 30.3% (mean: 13.8%). The biological half-life after IM or IV administration is 5.4 ± 1.0 h.  The serum half-life of lincomycin may be prolonged in patients with severe impairment of renal function, compared to patients with normal renal function. In patients with abnormal hepatic function, serum half-life may be twofold longer than in patients with normal hepatic function. Hemodialysis and peritoneal dialysis are not effective in removing lincomycin from the serum.