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STAY TUNED: ELIXI NEWS FROM THE WORLD
Abecma (idecabtagene vicleucel), First Cell-Based Gene Therapy for Adult Patients with Multiple Myeloma
3 April 2021
The U.S. Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy. Abecma is the first…
ARCALYST (rilonacept) is the first FDA-approved therapy for recurrent pericarditis
23 March 2021
The FDA has approved ARCALYST ® (rilonacept), a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling, for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12…
Evrysdi (Risdiplam), First oral treatment for spinal muscular atrophy (SMA)
27 February 2021
EMA has recommended granting a marketing authorisation in the European Union for the first treatment that can be given orally to patients with certain types of spinal muscular atrophy (SMA), a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement. Evrysdi…
Cosela (trilaciclib), first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression
14 February 2021
The FDA has approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage (when the cancer has spread beyond the lungs) small cell lung cancer. Cosela may…
Breyanzi (lisocabtagene maraleucel), new Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma
9 February 2021
The U.S. Food and Drug Administration has approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. Breyanzi, a…
RINVOQ™ (Upadacitinib), approved for the Treatment of Psoriatic Arthritis and Ankylosing Spondylitis
26 January 2021
The European Commission (EC) has approved RINVOQTM (upadacitinib, 15 mg), an oral, once daily selective and reversible JAK inhibitor for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be…
XALKORI (CRIZOTINIB) approved for ALK-POSITIVE anaplastic large cell LYMPHOMA in children and young adults
19 January 2021
The FDA has approved the supplemental New Drug Application (sNDA) for XALKORI® (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive.…
Enhertu (trastuzumab deruxtecan) first HER2-directed medicine approved in a decade for patients with HER2-positive metastatic gastric cancer
18 January 2021
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior…
Xofluza® (baloxavir marboxil), a first-in-class, single-dose oral medicine, for the treatment of influenza,
12 January 2021
The European Commission (EC) has approved Xofluza® (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged 12 years and above. In addition, the EC has approved Xofluza for post-exposure prophylaxis of influenza in individuals aged 12 years and above. Post-exposure…