The U.S. Food and Drug Admin­istra­tion (FDA) has given the go-ahead for what is likely to be the first clin­i­cal trial of an allo­geneic chi­meric an­ti­gen re­cep­tor (CAR) T-cell ther­apy for mul­ti­ple myeloma.

The poten­tial new myeloma CAR T-cell ther­apy, known as UCARTCS1, is being devel­oped by the French bio­pharma­ceu­tical com­pany Cellectis. The com­pany an­nounced earlier this week that the FDA approved its Investi­ga­tional New Drug (IND) appli­ca­tion for UCARTCS1 in late Jan­u­ary.

The IND ap­prov­al means Cellectis can move for­ward with its plans for MUNDI-01, a Phase 1 dose escalation trial …

Successful manu­fac­tur­ing and re­lease of GMP vials of UCARTCS1

New York, NY (Press Release) – Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a bio­pharma­ceu­tical com­pany focused on devel­op­ing immuno­therapies based on gene-edited CAR T-cells (UCART), an­nounced to­day that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the Com­pany’s Inves­ti­ga­tional New Drug (IND) appli­ca­tion to ini­ti­ate a Phase 1 clin­i­cal trial for UCARTCS1, in patients with mul­ti­ple myeloma (MM). The IND for UCARTCS1 was filed on De­cem­ber 28, 2018 and approved by the FDA within a month, on Jan­u­ary 25, 2019. Cellectis is the sponsor of the UCARTCS1 clin­i­cal study (MUNDI-01) and …

• In the ELOQUENT-3 trial, treat­ment with Empliciti plus poma­lido­mide and dexa­meth­a­sone (EPd) doubled median pro­gres­sion-free sur­vival and over­all re­sponse rate versus poma­lido­mide and dexa­meth­a­sone (Pd)¹
• Low dis­con­tinu­a­tion rates due to adverse reac­tions were observed with both EPd and Pd alone¹
• Empliciti, when used in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone, can be admin­istered once monthly after first two cycles¹

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) approved Empliciti (elo­tuzu­mab) in­jec­tion for intra­venous use in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (EPd) for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor.¹ In ELOQUENT-3, a ran­dom­ized, open-label, Phase 2 trial, EPd dem­onstrated ben­e­fit in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma, doubling both median pro­gres­sion-free sur­vival (PFS) …

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the Euro­pean Medicines Agency (EMA) has val­i­dated the Com­pany’s type II variation appli­ca­tion for Empliciti (elo­tuzu­mab) in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­cluding lena­lido­mide and a pro­te­a­some in­hib­i­tor (PI), and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. Validation of the appli­ca­tion con­firms the sub­mission is com­plete and begins the EMA’s centralized review process.

“Given the need for new treat­ment …

Application based on re­­sults from Phase 2 ELOQUENT-3 study

Princeton, NJ (Press Release) - Bristol-Myers Squibb Com­pany (NYSE:BMY) to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) ac­cepted its supple­mental Biologics License Appli­ca­tion (sBLA) for Empliciti (elo­tuzu­mab) in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of patients with re­lapsed / re­frac­tory mul­ti­ple myeloma (RRMM) who have re­ceived at least two prior ther­a­pies, in­­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor. The FDA granted the appli­ca­tion priority review with an action date of De­cem­ber 27, 2018.

“This file ac­ceptance is an im­por­tant step in BMS’s on­go­ing efforts to ad­vance …

The main mul­ti­ple myeloma-related poster session at this year's Amer­i­can Society of Clinical Oncology (ASCO) annual meeting in Chicago took place last Monday. Several of the posters pre­sented during that session focused on poten­tial new mul­ti­ple myeloma ther­a­pies. Those posters were reviewed in the Beacon's previous ASCO mul­ti­ple myeloma up­date.

In this, the Beacon's final ASCO 2016 up­date, the attention shifts to posters from the Monday session that were re­lated to existing myeloma ther­a­pies, as well as a pair of posters re­lated to smol­der­ing mul­ti­ple myeloma.

The posters about existing ther­a­pies …

Die Europäische Arzneimittelkommission hat Empliciti (Elotuzumab) für die Behandlung des multiplen Myeloms zugelassen.

Die Zulassung bedeutet, dass Myelompatienten in Europa mit Empliciti behandelt werden können, ohne sich in eine klinische Studie einschreiben zu müssen.

Die europäische Zulassung von Empliciti folgt der Zulassung in den Vereinigten Staaten im letzten November, dem Markt, auf dem das Medikament seine allererste Zulassung erhalten hat. Wie in den Vereinigten Staaten ist Empliciti in Europa für die Anwendung in Kombination mit Revlimid (Lenalidomid) und Dexamethason zugelassen worden.

Genauer gesagt ist die europäische Zulassung von Empliciti für die Anwendung …