Abecma hits the mark in earlier-stage multiple myeloma
Bristol-Myers Squibb is on course to move its BCMA-targeting CAR-T therapy further up the treatment pathway in multiple myeloma, after reporting that it met its […]
multiple myeloma
BMS reports data that could give its cell therapy an edge over rival J&J product
Bristol Myers Squibb has data showing that its multiple myeloma treatment Abecma beat the standard of care, preliminary Phase 3 results that could support moving […]
CHMP backs J&J’s myeloma bispecific Tecvayli, ahead of US decision
The EMA’s human medicines committee has recommended approval of Johnson & Johnson’s Tecvayli as a fourth-line therapy for multiple myeloma, joining a growing group of […]
ASCO22: J&J, Pfizer trade BCMA bispecific data in myeloma
Johnson & Johnson and Pfizer both highlighted new data with BCMA-targeting bispecific antibodies in patients with relapsed or refractory multiple myeloma (RRMM) at ASCO, previewing […]
J&J, Legend get EU nod for myeloma CAR-T Carvykti
Johnson & Johnson and Legend Biotech will arrive at next week’s ASCO congress with a new EU approval for multiple myeloma CAR-T Carvykti. The European […]
BCMA Targeted Therapies Summit
With the undeniable excitement in the BCMA field over the past few months, the BCMA Targeted Therapies Summit returns to the space to equip you […]
CHMP backs J&J’s myeloma CAR-T therapy Carvykti
Johnson & Johnson is in course for approval of its multiple myeloma CAR-T therapy Carvykti in the EU the next few weeks, after getting a […]
Blackstone funds new trials of Sanofi’s Sarclisa in myeloma
Sanofi has agreed a deal with life sciences investor Blackstone to help fund clinical trials of a new formulation of Sarclisa for blood cancer multiple […]
J&J, Legend win FDA nod for cell therapy challenger to BMS in multiple myeloma
Approval of the Johnson & Johnson and Legend Biotech cell therapy, Carvykti, marks the second CAR T-cell therapy to clear the regulatory bar for multiple […]
Janssen, Legend CAR-T therapy CARVYKTI gets FDA nod
The US Food and Drug Administration (FDA) has approved a new cell-based therapy for blood cancer, developed by Janssen and China’s Legend Biotech to treat […]
BMS cuts $3.15bn deal with Century for cancer cell therapies
Bristol-Myers Squibb chief executive Giovanni Caforio has promised to invest in the company’s pipeline at the virtual JP Morgan Healthcare Conference, and demonstrated that commitment […]
J&J goes after another FDA approval for a cancer bispecific
Johnson & Johnson’s much-touted crop of bispecific antibodies for cancer generated its first commercial product in May, and the drugmaker has now filed for FDA […]
Sanofi’s Sarclisa Combination Regimen Receives Health Canada’s Approval for Multiple Myeloma
Shots: The approval is based on P-III IKEMA study assessing Sarclisa in combination with carfilzomib and dexamethasone (Kd) in 302 patients with relapsed MM who […]
NICE rejects J&J’ Darzalex regimen for multiple myeloma
New guidance from NICE has rejected a combination regimen based on Johnson & Johnson’s Darzalex for a group of previously-untreated patients with multiple myeloma, a […]
BMS’ Abecma (Idecabtagene Vicleucel) Receives EC’s Conditional Approval for Relapsed and Refractory Multiple Myeloma
Shots: The conditional approval is based on KarMMa study evaluating Abecma (single infusion with a target dose of 420 x 106 CAR T cells) in […]
C4T’s CFT7455 Receives the US FDA’s Orphan Drug designation for the Treatment of Multiple Myeloma
Shots: The US FDA has granted ODD to CFT7455 for the treatment of MM. The FDA grants ODD to drugs & biologics that are intended […]
Janssen’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) + Pomalidomide and Dexamethasone Receive the US FDA’s Approval to Treat Patients with Multiple Myeloma
Shots: The approval is based on P-III APOLLO study evaluating Darzalex Faspro (SC) + pomalidomide & dexamethasone (Pd) vs Pd alone in 304 patients with […]
BeiGene’s Kyprolis (carfilzomib) Receives NMPA’s Conditional Approval for the Treatment of Relapsed or Refractory Multiple Myeloma
Shots: The approval is based on P-III trial evaluating efficacy & safety of Kyprolis + dexamethasone in 123 patients with RRMM who have received at […]
Sanofi Signs ~$1B Agreement with Eureka & MSK for their Multiple Myeloma Candidate
Shots: Eureka and MSK are eligible to receive up front and ~$1B as development, regulatory and sales milestone along with royalties on net sales. Sanofi […]
Janssen Presents Results of Darzalex (daratumumab) in P-III MAIA Study for Transplant Ineligible Patients with Multiple Myeloma at EHA 2021
Shots: The P-III MAIA study assessing Darzalex + lenalidomide & dexamethasone (DRd) vs Rd in 737 newly diagnosed patients aged 45-90yrs. with MM ineligible for […]
Janssen’s Teclistamab Receives the US FDA’s Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma
Shots: The FDA’s BT and EMA’s PRIME designations are based on data from the P-I MajesTEC-1 study evaluating the safety and efficacy of teclistamab (Ab […]
FDA sets November review date for J&J’s multiple myeloma CAR-T cilta-cel
Johnson & Johnson has secured a six-month FDA review for its multiple myeloma CAR-T therapy ciltacabtagene autoleucel (cilta-cel), narrowing the lead for Bristol-Myers Squibb and […]
Straight after its first cancer bispecific OK, J&J highlights two more at ASCO
With the ink barely dry on the FDA’s approval of Johnson & Johnson’s Rybrevant, its first bispecific antibody for cancer, the drugmaker is already showcasing […]
Janssen files its first CAR-T therapy cilta-cel in Europe
Johnson & Johnson’s Janssen unit has filed for approval of its multiple myeloma CAR-T ciltacabtagene autoleucel in Europe, chasing after a rival therapy from Bristol-Myers […]
Janssen Reports MAA Submission to EMA for Cilta-cel to Treat Relapsed/ Refractory Multiple Myeloma
Shots: The application is based on P-Ib/II CARTITUDE-1 study evaluating cilta-cel in adults with r/r MM who have received at least prior 3L therapies across […]
Sanofi’s Sarclisa (isatuximab) Receives EC’s Approval for Adults with Relapsed and Refractory Multiple Myeloma
Shots: The approval is based on data from the P-III IKEMA study evaluating Sarclisa + carfilzomib and dexamethasone (Kd) vs Kd alone in 302 patients […]
Sanofi’s Sarclisa gains new US multiple myeloma indication
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. […]
Bristol Myers Squibb wins first CAR-T therapy approval in multiple myeloma
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 […]
FDA approves BMS’ multiple myeloma CAR-T Abecma
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 […]
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
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 […]
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 […]
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 […]
BCMA Targeted Therapies Summit
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 […]
Janssen Reports CHMP’s Acceptance for Accelerated Assessment of Cilta-cel’s MAA to Treat Patients with Heavily Pretreated Multiple Myeloma
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 […]
NICE reverses stance on Celgene’s Revlimid for myeloma maintenance
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 […]
Henlius’ HLX15 (biosimilar, daratumumab) Receives IND Approval for Multiple Myeloma in China
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 […]
Pfizer/ OPKO Health’s Somatrogon; FDA EU for SCONE device; Antengene ATG-010 for rrMM and rrDLBCL; SanBio STEMTRA Phase 2 Interim Results
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 […]
Janssen Initiates Rolling Submission of BLA to US FDA of Autoleucel (cilta-cel) to Treat Multiple Myeloma
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) […]
Janssen’s Darzalex (daratumumab) Receives Health Canada Approval for the Treatment of 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 […]
Chasing BMS, J&J files BCMA CAR-T for multiple myeloma to FDA
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 […]
Henlius Report the NMPA’s Acceptance of HLX15 (biosimilar, Daratumumab) to Treat Multiple Myeloma
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 […]
Janssen combines Darzalex with COVID drug in new multiple myeloma submission
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 […]
Sanofi’s Sarclisa (isatuximab) Receives NICE Recommendation for Patients with Multiple Myeloma
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 […]
GSK moves further ahead in BCMA with EU okay for Blenrep
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 […]
GSK nabs FDA approval for first-in-class multiple myeloma drug
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 […]
FDA approves GSK’s Blenrep for advanced multiple myeloma
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 […]
Janssen’s Darzalex (daratumumab, SC) Receives Health Canada Approval for the Treatment of Patients with 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 […]
BMS, bluebird refile FDA approval application for CAR-T therapy in 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 […]
BMS ‘bet’ with Celgene shareholders in balance after CAR-T refile
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 […]
CHMP gives nod to GSK’s BCMA drug Blenrep for myeloma
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, […]
FDA AdCom votes unanimously in favor of GSK myeloma drug, despite earlier agency skepticism
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 raises concerns over ocular toxicity from GSK’s potential first-in-class myeloma drug
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 […]
FDA slaps hold on Cellectis’ off-the-shelf myeloma CAR-T trial after patient death
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 […]
Does Aspartame Cause Lymphoma?
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 […]
