The FDA has approved Sanofi’s Sarclisa (isatuximab) in combination with a new chemotherapy regimen for advanced multiple myeloma, building on a first approval last year. This label extension covers use of Sarclisa plus carfilzomib and dexamethasone for adults with relapsed or refractory multiple myeloma, who… Read More »Sanofi’s Sarclisa gains new US multiple myeloma indication
The FDA has approved a Bristol Myers Squibb cell therapy made by engineering a patient’s immune cells to target a cancer protein called BCMA. The regulatory decision for Abecma in multiple myeloma gives BMS its second approved CAR-T therapy.
The FDA has approved Bristol-Myers Squibb’s Abecma (idecabtagene vicleucel) for multiple myeloma, the first cell therapy to treat the disease. Abecma’s review was delayed after the FDA rejected a first filing in May last year, but it’s hoped that the drug could be a significant… Read More »FDA approves BMS’ multiple myeloma CAR-T Abecma
Shots: The approval is based on the P-II KarMMa trial that involves assessing Abecma in 127 patients with r/r MM prior treated with 3L+ therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 Ab Results: ORR (72%); sCR (28%); mDoR (11mos.); responses were… Read More »BMS and bluebird bio’s Abecma (idecabtagene vicleucel) Receive the US FDA’s Approval as the First Anti-BCMA CAR T Cell Therapy for R/R Multiple Myeloma
NICE has recommended funding for two cancer drug combinations for ovarian cancer and multiple myeloma. In final draft guidance that applies to England, NICE said AstraZeneca/MSD’s Lynparza (olaparib) plus Roche’s Avastin (bevacizumab) should be reimbursed by the Cancer Drugs Fund in people with ovarian cancer… Read More »NICE backs ovarian cancer and multiple myeloma combination drugs
NICE has recommended funding for two cancer drug combinations for ovarian cancer and multiple myeloma. In final draft guidance that applies to England, NICE said AstraZeneca/MSD’s Lynparza (olaparib) plus Roche’s Avastin (bevacizumab) should be reimbursed by the Cancer Drugs Fund in people with ovarian cancer… Read More »NICE backs ovarian cancer and multiple myeloma combination drugs
Built with thought leaders from Seattle Genetics, Precision Biosciences and Kite Pharma, the inaugural industry-focused BCMA Targeted Therapies Summit will share the field’s cutting-edge and aggressive scientific advances of BCMA therapies within multiple myeloma. This summit is the first of its kind, uniting thought leaders… Read More »BCMA Targeted Therapies Summit
Shots: The MAA submission is based on a P-Ib/II CARTITUDE-1 study assessing the safety and efficacy of cilta-cel in adults with r/r MM. The company is expected to submit MAA to EMA in H1’21 The accelerated approval milestone in EU follows the rolling submission for… Read More »Janssen Reports CHMP’s Acceptance for Accelerated Assessment of Cilta-cel’s MAA to Treat Patients with Heavily Pretreated Multiple Myeloma
NHS patients in England with newly-diagnosed multiple myeloma can be treated with Celgene’s Revlimid as maintenance therapy after a stem cell transplant, after new guidance from NICE. The cost-effectiveness agency has backed interim funding for Revlimid (lenalidomide) in this setting via the Cancer Drugs Fund… Read More »NICE reverses stance on Celgene’s Revlimid for myeloma maintenance
Shots: Henlius reported that NMPA has approved the IND application of HLX15 for the treatment of multiple myeloma The company has compared HLX15 in a head to head study with reference daratumumab via analytical & preclinical studies. The results demostrated that HLX15 is highly similar… Read More »Henlius’ HLX15 (biosimilar, daratumumab) Receives IND Approval for Multiple Myeloma in China
Pfizer and OPKO Health: A step closer to FDA Nod for pediatric growth hormone deficiency (GHD) drug, Somatrogon Pfizer and Opko had joined hands in 2014 to develop somatrogon, a pediatric growth hormone deficiency (GHD) drug. It comprises the natural sequence of growth hormone and… Read More »Pfizer/ OPKO Health’s Somatrogon; FDA EU for SCONE device; Antengene ATG-010 for rrMM and rrDLBCL; SanBio STEMTRA Phase 2 Interim Results
Shots: Janssen Initiates Rolling Submission of BLA to US FDA is based on P-lb/ll CARTITUDE-1 Study involve evaluating the safety and efficacy of Autoleucel (cilta-cel) in adults for the treatment of relapsed and refractory Multiple Myeloma The FDA granted BTD for cilta-cel and agreed to… Read More »Janssen Initiates Rolling Submission of BLA to US FDA of Autoleucel (cilta-cel) to Treat Multiple Myeloma
Shots: The approval is based on P-lll CASSIOPEIA (MMY3006) Study involve the assessing of Darzalex (daratumumab) + bortezomib, thalidomide, and dexamethasone (VTd) for the treatment of patients with multiple myeloma are eligible for (ASCT) Result: The 1EPs of sCR rate post-transplant was significantly higher (29… Read More »Janssen’s Darzalex (daratumumab) Receives Health Canada Approval for the Treatment of Multiple Myeloma
Johnson & Johnson’s Janssen unit has filed a rolling submission for its multiple myeloma CAR-T ciltacabtagene autoleucel (cilta-cel) to the FDA, in hot pursuit of Bristol-Myers Squibb’s delayed rival therapy. Cilta-cel – which targets B-cell maturation antigen (BCMA) – has been submitted as a treatment… Read More »Chasing BMS, J&J files BCMA CAR-T for multiple myeloma to FDA
Shots: The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to… Read More »Henlius Report the NMPA’s Acceptance of HLX15 (biosimilar, Daratumumab) to Treat Multiple Myeloma
Janssen has submitted a new combination regimen for its blockbuster multiple myeloma drug Darzalex for approval with the FDA and EMA, hoping to give the treatment another edge over emerging competitors. Specifically, the combination utilises the subcutaneous formulation of the drug, Darzalex Faspro (daratumumab/hyaluronidase) with… Read More »Janssen combines Darzalex with COVID drug in new multiple myeloma submission
Shots: The NICE has issued FAD which is based on the P-III ICARIA-MM trial assessing isatuximab + pom-dex vs pom-dex in patients prior treated with 3L treatment and at least 2L therapies including lenalidomide and a proteasome inhibitor with RRMM in 307 patients with RRMM… Read More »Sanofi’s Sarclisa (isatuximab) Receives NICE Recommendation for Patients with Multiple Myeloma
GlaxoSmithKline has approval on both sides of the Atlantic for its multiple myeloma drug Blenrep, after getting the nod from the European Commission. Blenrep (belantamab mafodotin) becomes the first BCMA-targeted drug for myeloma to be approved in the EU, and according to its label can… Read More »GSK moves further ahead in BCMA with EU okay for Blenrep
Blenrep, an antibody-drug conjugate, is the first drug approved for multiple myeloma that targets the antigen BCMA. Several other companies are also developing BCMA-targeting therapies for the blood cancer, including CAR-T cells and bispecific antibodies.
The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease. Blenrep (belantamab mafodotin) has been approved in patients who have received at least four therapies including an anti-CD38 such as Darzalex, a proteasome inhibitor and… Read More »FDA approves GSK’s Blenrep for advanced multiple myeloma
Shots: The Health Canada has approved Darzalex SC (daratumumab) in four regimens across five indications in patients with MM, notably newly diagnosed, transplant-ineligible patients as well as relapsed/refractory patients The approval is based on P-III COLUMBA and P-II PLEIADES studies. The P-III study demonstrated a… Read More »Janssen’s Darzalex (daratumumab, SC) Receives Health Canada Approval for the Treatment of Patients with Multiple Myeloma
The companies’ resubmission of their application Wednesday seeking approval for idecabtagene vicleucel was in line with the timeline they provided in May, when the FDA sent a refuse-to-file letter in response to their initial submission.
Bristol-Myers Squibb and bluebird bio have refiled their CAR-T therapy for multiple myeloma, leaving the outcome of a three drug “bet” with former Celgene shareholders dependent on a fast review from the FDA. BMS gave Celgene’s shareholders a “Contingent Value Right” (CVR) to sweeten the… Read More »BMS ‘bet’ with Celgene shareholders in balance after CAR-T refile
GlaxoSmithKline is closing in on EU approval for its first-in-class BCMA-targeting drug Blenrep, after getting a green light from the EMA’s human medicines committee. Blenrep, based on the antibody-drug conjugate belantamab mafodotin, has been recommended for conditional approval by the CHMP in adult patients with… Read More »CHMP gives nod to GSK’s BCMA drug Blenrep for myeloma
The Oncologic Drugs Advisory Committee voted 12-0 that the benefit-risk profile of belantamab mafodotin supported the drug. The vote came despite concerns expressed by the FDA in briefing documents ahead of the ODAC meeting, particularly with regard to ocular toxicity.
The FDA’s Oncologic Drugs Advisory Committee will convene Tuesday to discuss the drug, belantamab mafodotin. Despite the drug’s first-in-class potential, the briefing document for the meeting raised concerns about eye toxicity and questions about its risk-benefit profile.
The patient, who had been enrolled in the Phase I study at the higher dose level of UCARTCS1A, suffered a cardiac arrest, the causes of which are under investigation, the company said.
The approval of aspartame has a controversial history. The Commissioner of the U.S. Food and Drug Administration (FDA) concluded that “there is a reasonable certainty that human consumption of aspartame: (1) …will not pose a risk of brain damage resulting in mental retardation, endocrine [hormonal]… Read More »Does Aspartame Cause Lymphoma?