multiple myeloma

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 have received 1 to 3 prior lines of therapy across 69 centers spanning 16 countries The addition of Kd in Sarclisa leads to a 47% reduction in the risk of …

Sanofi’s Sarclisa Combination Regimen Receives Health Canada’s Approval for Multiple Myeloma Read More »

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 type of bone marrow cancer. The draft document covers the use of Darzalex (daratumumab) as an add-on to standard induction treatment with Takeda’s Velcade (bortezomib) plus thalidomide and dexamethasone given …

NICE rejects J&J’ Darzalex regimen for multiple myeloma Read More »

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 128 patients with r/r MM prior treated with 3L therapies including an immunomodulatory agent, a proteasome inhibitor & an anti-CD38 Ab and who are refractory to their last treatment Results: …

BMS’ Abecma (Idecabtagene Vicleucel) Receives EC’s Conditional Approval for Relapsed and Refractory Multiple Myeloma Read More »

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 for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the US In Jun’21, the company has initiated a …

C4T’s CFT7455 Receives the US FDA’s Orphan Drug designation for the Treatment of Multiple Myeloma Read More »

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 RRMM who have received at least one prior treatment regimen including lenalidomide & a proteasome inhibitor The study met its 1EPs of PFS & showed 37% reduction in risk of …

Janssen’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) + Pomalidomide and Dexamethasone Receive the US FDA’s Approval to Treat Patients with Multiple Myeloma Read More »

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 least 2 prior therapies, including a proteasome inhibitor & an immunomodulatory agent Results: ORR (35.8%); m-PFS (5.6mos.) as assessed by IRC. Additionally, results showed that the efficacy & safety in …

BeiGene’s Kyprolis (carfilzomib) Receives NMPA’s Conditional Approval for the Treatment of Relapsed or Refractory Multiple Myeloma Read More »

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 gets exclusive rights to the GPRC5D binder for non-CAR use Eureka discovered the GPRC5D binding domain using its E-ALPHA Abs discovery platform, under its collaboration with MSK Additionally, targeting GPRC5D …

Sanofi Signs ~$1B Agreement with Eureka & MSK for their Multiple Myeloma Candidate Read More »

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 high-dose CT & ASCT MAIA longer-term follow-up analysis showed i.e @5yrs., OS rate (66% vs 53%), PFS rate (53% vs 29%), ORR (93% vs 82%) & median time to next …

Janssen Presents Results of Darzalex (daratumumab) in P-III MAIA Study for Transplant Ineligible Patients with Multiple Myeloma at EHA 2021 Read More »

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 targeting BCMA and CD3) in adults with r/rMM. The findings will be presented at ASCO 2021 In preclinical studies, the therapy kills myeloma cell lines and bone marrow-derived myeloma cells …

Janssen’s Teclistamab Receives the US FDA’s Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma Read More »

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 bluebird bio’s rival Abecma. The US regulator is now scheduled to complete its review of cilta-cel by 29 November for adults with relapsed and/or refractory multiple myeloma who have previously …

FDA sets November review date for J&J’s multiple myeloma CAR-T cilta-cel Read More »

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 others in its pipeline.  Two of its earlier-stage bispecifics – both in development for the blood cancer multiple myeloma – will feature at the American Society of Clinical Oncology (ASCO) …

Straight after its first cancer bispecific OK, J&J highlights two more at ASCO Read More »

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 Squibb.  The BCMA-targeting CAR-T – also known as cilta-cel – has been filed with the EMA as a treatment for adults with relapsed/refractory multiple myeloma, an incurable form of blood …

Janssen files its first CAR-T therapy cilta-cel in Europe Read More »

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 the US, EU, China, and Japan The 1EP of the P-Ib study is to characterize the safety and confirm the dose of the therapy while the primary objective of P-II …

Janssen Reports MAA Submission to EMA for Cilta-cel to Treat Relapsed/ Refractory Multiple Myeloma Read More »

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 with relapsed MM across 69 centers spanning 16 countries Results: mPFS (not reached vs 19.15 mos.) at the time of the pre-planned interim analysis, reduction in the risk of disease …

Sanofi’s Sarclisa (isatuximab) Receives EC’s Approval for Adults with Relapsed and Refractory Multiple Myeloma Read More »

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. This label extension covers use of Sarclisa plus carfilzomib and dexamethasone for adults with relapsed or refractory multiple myeloma, who have received one to three previous therapy lines. This new …

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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 the FDA rejected a first filing in May last year, but it’s hoped that the drug could be a significant step forward in the treatment of this incurable condition. It …

FDA approves BMS’ multiple myeloma CAR-T Abecma 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

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 rapid and durable, with a median time to response of …

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 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 that have responded to platinum chemotherapy. Early results from the …

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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 that have responded to platinum chemotherapy. Early results from the …

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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 aggressive scientific advances of BCMA therapies within multiple myeloma. This summit is the first of its kind, uniting thought leaders in BCMA therapeutics drug development to discuss their challenges and …

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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 is expected to submit MAA to EMA in H1’21 The accelerated approval milestone in EU follows the rolling submission for cilta-cel to the US FDA in Dec’2020 Cilta-cel is an …

Janssen Reports CHMP’s Acceptance for Accelerated Assessment of Cilta-cel’s MAA to Treat Patients with Heavily Pretreated Multiple Myeloma Read More »

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 from NICE. The cost-effectiveness agency has backed interim funding for Revlimid (lenalidomide) in this setting via the Cancer Drugs Fund (CDF), which provides temporary reimbursement for medicines until further data …

NICE reverses stance on Celgene’s Revlimid for myeloma maintenance Read More »

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 head to head study with reference daratumumab via analytical & preclinical studies. The results demostrated that HLX15 is highly similar to reference daratumumab The company has developed the HLX15 in …

Henlius’ HLX15 (biosimilar, daratumumab) Receives IND Approval for Multiple Myeloma in China 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

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 a copy of the C-terminal peptide (CTP) from the beta …

Pfizer/ OPKO Health’s Somatrogon; FDA EU for SCONE device; Antengene ATG-010 for rrMM and rrDLBCL; SanBio STEMTRA Phase 2 Interim Results Read More »

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) in adults for the treatment of relapsed and refractory Multiple Myeloma The FDA granted BTD for cilta-cel and agreed to BLA’s rolling review includes completed portions of the application to …

Janssen Initiates Rolling Submission of BLA to US FDA of Autoleucel (cilta-cel) to Treat Multiple Myeloma Read More »

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 of patients with multiple myeloma are eligible for (ASCT) Result: The 1EPs of sCR rate post-transplant was significantly higher (29 % vs. 20 %); median follow-up (18.8 mos.); reduction in …

Janssen’s Darzalex (daratumumab) Receives Health Canada Approval for the Treatment of Multiple Myeloma Read More »

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 Bristol-Myers Squibb’s delayed rival therapy. Cilta-cel – which targets B-cell maturation antigen (BCMA) – has been submitted as a treatment for patients with relapsed or refractory myeloma, an incurable form …

Chasing BMS, J&J files BCMA CAR-T for multiple myeloma to FDA Read More »

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 treatment The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to its reference daratumumab while the safety profiles are also similar …

Henlius Report the NMPA’s Acceptance of HLX15 (biosimilar, Daratumumab) to Treat Multiple Myeloma Read More »

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 treatment another edge over emerging competitors. Specifically, the combination utilises the subcutaneous formulation of the drug, Darzalex Faspro (daratumumab/hyaluronidase) with Celgene’s multiple myeloma drug Imnovid (pomalidomide) and dexamethasone – which …

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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 3L treatment and at least 2L therapies including lenalidomide and a proteasome inhibitor with RRMM in 307 patients with RRMM The study demonstrated that the combination regimen demonstrated a reduction …

Sanofi’s Sarclisa (isatuximab) Receives NICE Recommendation for Patients with Multiple Myeloma Read More »

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 mafodotin) becomes the first BCMA-targeted drug for myeloma to be approved in the EU, and according to its label can be used to treat the blood cancer in adult patients …

GSK moves further ahead in BCMA with EU okay for Blenrep Read More »

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 for the blood cancer, including CAR-T cells and bispecific antibodies.

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 approved in patients who have received at least four therapies including an anti-CD38 such as Darzalex, a proteasome inhibitor and an immunomodulatory agent. This is an accelerated approval based on …

FDA approves GSK’s Blenrep for advanced multiple myeloma Read More »

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 well as relapsed/refractory patients The approval is based on P-III COLUMBA and P-II PLEIADES studies. The P-III study demonstrated a consistent ORR (41% vs 37%), with PK & safety profile …

Janssen’s Darzalex (daratumumab, SC) Receives Health Canada Approval for the Treatment of Patients with Multiple Myeloma Read More »

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 sent a refuse-to-file letter in response to their initial submission.

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 dependent on a fast review from the FDA. BMS gave Celgene’s shareholders a “Contingent Value Right” (CVR) to sweeten the $74 billion merger last November. Each shareholder got one CVR …

BMS ‘bet’ with Celgene shareholders in balance after CAR-T refile Read More »

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, based on the antibody-drug conjugate belantamab mafodotin, has been recommended for conditional approval by the CHMP in adult patients with the blood cancer multiple myeloma whose disease has progressed despite …

CHMP gives nod to GSK’s BCMA drug Blenrep for myeloma Read More »

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 in briefing documents ahead of the ODAC meeting, particularly with regard to ocular toxicity.

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 meeting raised concerns about eye toxicity and questions about its risk-benefit profile.

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 that human consumption of aspartame: (1) …will not pose a risk of brain damage resulting in mental retardation, endocrine [hormonal] dysfunction, or both; and (2) will not cause brain tumors.” …

Does Aspartame Cause Lymphoma? Read More »