News
STAY TUNED: ELIXI NEWS FROM THE WORLD
Rozlytrek, Roche’s first tumour-agnostic therapy, approved in Europe for people with NTRK fusion-positive solid tumours and for people with ROS1-positive advanced non-small cell lung cancer
14 August 2020
The European Commission has granted conditional marketing authorisation for Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is…
Blenrep (belantamab mafodotin), new option for the treatment of relapsed and refractory multiple myeloma
24 July 2020
EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation in the European Union for Blenrep (belantamab mafodotin) to treat adult patients with relapsed and refractory multiple myeloma who no longer respond to treatment with an immunomodulatory agent, a…
Inqovi (decitabine and cedazuridine), new Therapy for Myelodysplastic Syndromes (MDS) That Can Be Taken at Home
14 July 2020
Inqovi (decitabine and cedazuridine) tablets is a new FDA approved treatment of adult patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). This represents an important advance in treatment options for patients with MDS, a type of blood cancer, who previously…
Rukobia (fostemsavir), a new antiretroviral medication for patients who have run out of HIV treatment options
7 July 2020
Rukobia (fostemsavir), is a newly approved type of antiretroviral medication for adults living with HIV who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations. “This approval…
Uplizna (inebilizumab-cdon)Therapy for Neuromyelitis Optica Spectrum Disorder Offers Patients Additional Treatment Option
12 June 2020
The FDA has approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients with a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody positive). NMOSD is a rare autoimmune disease of the…
FDA Approves Merck’s RECARBRIO (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)
6 June 2020
The FDA has approved a supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) for the treatment of patients 18 years of age and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following…
FDA Approves Oriahnn (an estrogen and progestin combination product consisting of elagolix, estradiol and norethindrone acetate)to Treat Heavy Menstrual Bleeding Associated with Fibroids in Women
29 May 2020
Oriahnn (an estrogen and progestin combination product consisting of elagolix, estradiol and norethindrone acetate) capsules, co-packaged for oral use, has been approved by the FDA for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.…
Qinlock (ripretinib) is the First Drug for Fourth-Line Treatment of Advanced Gastrointestinal Stromal Tumors
19 May 2020
The FDA has approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST), a type of tumor that originates in the gastrointestinal tract. Qinlock is indicated for adult patients who have received prior…
Novartis announces FDA approval of MET inhibitor Tabrecta (capmatinib)for metastatic non-small cell lung cancer with METex14
11 May 2020
Novartis has announced that the US Food and Drug Administration (FDA) approved Tabrecta (capmatinib), an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved…