Pharmacist Digest

FDA clears IND for Gracell Biotechnologies’ phase 1 clinical trial for multiple myeloma treatment

Pharmafile

JANUARY 30, 2024

Gracell Biotechnologies has announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application, which allows them to initiate a phase 1 trial of GC012F in the US for the early-line treatment of multiple myeloma (ELMM).

STAT+: FDA advisers back CAR-T therapies in blood cancer, despite safety concerns

STAT

MARCH 15, 2024

The group voted 11-0 that the benefits of Carvykti, a CAR-T medicine from Johnson & Johnson and Legend Biotech, outweighed its risk for patients with multiple myeloma whose disease has persisted despite initial treatment. In clinical trials, each drug proved to significantly delay disease progression compared to standard therapy.

STAT+: A CAR-T from Bristol Myers benefits myeloma patients at earlier stage of care

STAT

FEBRUARY 10, 2023

The CAR-T cancer therapy called Abecma reduced the risk of multiple myeloma relapse by half compared to standard treatment, according to results of a Phase 3 clinical trial published Friday.

STAT+: What to make of Gilead’s Trodelvy troubles and Elevation Oncology’s surprising rise

STAT

JANUARY 25, 2024

Gilead needs Arcellx more than ever The clinical trial setback for Trodelvy in non-small cell lung cancer reported by Gilead Sciences on Monday was another dose of bad news for the company’s oncology business. Continue to STAT+ to read the full story…

Molecular Templates Reports the US FDA's Clinical Hold on P-I Study of MT-0169 for Relapsed Multiple Myeloma

PharmaShots

APRIL 10, 2023

Shots: The US FDA has placed a partial clinical hold on the P-I study of MT-0169 in patients with relapsed multiple myeloma. Both the participants completely recovered within 2mos.

Dosage

Heidelberg Pharma gains FDA ODD for ATAC candidate

Pharmafile

MARCH 27, 2024

Heidelberg Pharma has announced that it has gained Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for HDP-101 for the treatment of multiple myeloma. The candidate is currently being investigated in a phase 1/2a clinical trial for the treatment of relapsed and refractory multiple myeloma (RRMM).

Multiple myeloma bispecific antibody granted accelerated approval

European Pharmaceutical Review

AUGUST 10, 2023

The US Food and Drug Administration (FDA) has granted accelerated approval of TALVEY (talquetamab-tgvs) to treat multiple myeloma. Multiple myeloma MonumenTAL-1 study In the dose-escalation MonumenTAL-1 study, which incorporated Phase I and Phase II , over 300 patients were enrolled. A median duration of follow-up of 10.4

Pharmaceutical Companies

Pharmaceutical Companies Pharmaceutical Companies

Preventative approach could reduce immunotherapy side effects

European Pharmaceutical Review

JANUARY 4, 2024

New research from the US indicates that a prophylactic treatment before immunotherapy can significantly reduce the rate of cytokine release syndrome (CRS) in multiple myeloma patients. The drug tocilizumab for example, has been used historically to treat CRS from immunotherapies.

Immunity

Immunity Immunization Hospitals Drug Development

BCMA-GPRC5D CAR-T Cells by Guangzhou Bio-gene Technology for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 7, 2024

BCMA-GPRC5D CAR-T Cells is under clinical development by Guangzhou Bio-gene Technology and currently in Phase II for Relapsed Multiple Myeloma.

FDA grants orphan drug status to Poseida’s multiple myeloma therapy

Pharmaceutical Business Review

MARCH 14, 2024

The allogeneic CAR-T product candidate is being developed in partnership with Roche for relapsed/refractory multiple myeloma (RRMM). Currently, the therapy is being evaluated in a Phase I clinical trial. P-BCMA-ALLO1 targets the B-cell maturation antigen (BCMA) and is enriched with T stem cell memory (TSCM) cells.

Chemotherapy

GEN-3014 by Genmab for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 8, 2024

GEN-3014 is under clinical development by Genmab and currently in Phase II for Relapsed Multiple Myeloma.

STAT+: Pharmalittle: GSK pulls a key blood-cancer drug off the market; Teva picks a new CEO

STAT

NOVEMBER 22, 2022

market after it failed in a key clinical trial, Reuters reports. The drug, Blenrep, won accelerated FDA approval in 2020 for patients with advanced multiple myeloma that had endured despite four lines of treatment. … GSK is pulling a top-selling treatment for blood cancer off the U.S.

FDA Grants Priority Review to Novel Bispecific Antibody for Multiple Myeloma

Pharmaceutical Commerce

FEBRUARY 21, 2024

Regeneron Pharmaceuticals’ linvoseltamab is currently in clinical development to treat adult patients with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies.

FDA APPROVES BMS AND J&J CAR-T CELL THERAPIES FOR THE EARLIER TREATMENT OF MULTIPLE MYELOMA

Big Molecule Watch

APRIL 11, 2024

announced that the FDA has approved ABECMA (idecabtagene vicleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.

Labelling

Minimizing Terms in Multiple Myeloma Clinical Trials May Inaccurately Reflect Tolerability, Rates of AEs

Pharmacy Times

NOVEMBER 20, 2023

The study authors suggest that future research should instead emphasize event rates and patient-reported outcomes to better evaluate the tolerability and frequency of AEs.

CHMP meeting highlights: February 2024

European Pharmaceutical Review

FEBRUARY 26, 2024

Clinical data showed approximately 60 percent reductions in plasma NfL concentrations in patients given Qalsody compared to placebo. After 12 weeks, patients treated with danicopan had a clinically-relevant increase in haemoglobin (an average of 2.35 This indicated reduced neuronal injury, EMA noted.

Generic Medicine

Generic Medicine Vaccines Pharmaceutical Companies Pharmaceutical Companies

NICE recommends all-oral treatment for multiple myeloma

European Pharmaceutical Review

JANUARY 19, 2023

The National Institute for Health and Care Excellence (NICE) has recommended Ninlaro ® (ixazomib) with lenalidomide and dexamethasone for treating relapsed/refractory multiple myeloma (RRMM). It was the first oral proteasome inhibitor to enter Phase III clinical trials and to receive a regulatory approval.

Hospitals

Hospitals Documentation

Glenmark and Ichnos launch Ichnos Glenmark Innovation to accelerate new drug discovery in cancer treatment

Express Pharma

JANUARY 30, 2024

Glenmark Pharmaceuticals and Ichnos Sciences, its global fully integrated, clinical-stage biotech subsidiary, announced the launch of their alliance – Ichnos Glenmark Innovation – to accelerate new drug discovery in cancer treatment. Two of these molecules have received orphan drug designation from the US FDA.

Assessing Clinical Trial Efficacy vs Real-World Effectiveness in the Management of Multiple Myeloma

Pharmacy Times

JANUARY 22, 2024

There is a significant efficacy-effectiveness gap in standard-of-care regimens.

EMA CHMP provides positive opinion for Janssen’s multiple myeloma therapy

Pharmaceutical Business Review

FEBRUARY 26, 2024

A chimeric antigen receptor T-cell (CAR-T) therapy, cilta-cel acts on B-cell maturation antigen (BCMA), a protein prevalent on myeloma cells. The CHMP’s positive stance is based on data from the CARTITUDE-4 study, a randomised Phase III clinical trial designed to compare cilta-cel’s efficacy and safety to standard treatments.

NICE publishes draft nod for Darzalex combo to treat multiple myeloma

Pharmaceutical Technology

APRIL 24, 2023

The National Institute for Health and Care Excellence (NICE) has published a final draft guidance recommending the use of Darzalex (daratumumab) with bortezomib and dexamethasone (DVd) for adults with previously treated multiple myeloma. Myeloma is a treatable but incurable type of bone marrow cancer.

Documentation

GSK will pull Blenrep from US market after failed trial

pharmaphorum

NOVEMBER 22, 2022

GSK confirmed this morning that the disappointing readout from the DREAMM-3 trial of multiple myeloma therapy Blenrep reported earlier this month means that it will take the drug off the US market. Some patients will be able to continue to receive the drug via a compassionate use programme.

FDA Accepts Priority Review for Linvoseltamab to Treat Adult Patients With R/R MM

Pharmacy Times

FEBRUARY 22, 2024

Currently, the safety and efficacy of linvoseltamab in adult patients with relapsed or refractory multiple myeloma is being compared to elotuzumab, pomalidomide, and dexamethasone in a phase 3 clinical trial.

New blood cancer treatment appears successful for most trial patients

Pharmafile

DECEMBER 12, 2022

A new and experimental immunotherapy treatment has appeared successful in treating patients with multiple myeloma in an ongoing phase 1/2 clinical trial. The blood cancer treatment has seen successful response rates in 73% of patients, and an application has been submitted to the FDA to bring the drug to market. read more.

Eftozanermin alfa by AbbVie for Refractory Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

OCTOBER 27, 2023

Eftozanermin alfa is under clinical development by AbbVie and currently in Phase I for Refractory Multiple Myeloma.

FDA committee recommends BMS-2seventy’s Abecma

Pharmaceutical Business Review

MARCH 17, 2024

Recently, Abecma received approval in Japan and Switzerland for patients with relapsed and/or refractory multiple myeloma who have received a minimum of two therapies previously. These therapies comprise an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

BCMA-GPRC5D CAR-T Cells by Guangzhou Bio-gene Technology for Refractory Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 7, 2024

BCMA-GPRC5D CAR-T Cells is under clinical development by Guangzhou Bio-gene Technology and currently in Phase II for Refractory Multiple Myeloma.

Assessing Clinical Trial Efficacy Vs Real-World Effectiveness in the Treatment of Multiple Myeloma

Pharmacy Times

DECEMBER 9, 2023

The efficacy of treatments, which is the outcomes in the ideal clinical trial setting, are known to often be better than the effectiveness of those treatments, which are the outcomes of patients in the real-world setting.

Kite and Arcellx enter partnership for multiple myeloma therapy development

Pharmaceutical Technology

DECEMBER 12, 2022

Gilead company Kite has entered an international strategic partnership with Arcellx for the joint development and commercialisation of the latter’s T-cell therapy, CART-ddBCMA, to treat relapsed or refractory multiple myeloma patients. Additionally, Kite will make other potential payments to Arcellx.

Communication

GEN-3014 by Genmab for Refractory Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 8, 2024

GEN-3014 is under clinical development by Genmab and currently in Phase II for Refractory Multiple Myeloma.

Breakthrough Therapy Designation for Pfizer bispecific antibody

European Pharmaceutical Review

NOVEMBER 7, 2022

has announced its B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb) elranatamab for relapsed or refractory multiple myeloma (RRMM) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). Elranatamab clinical trial data. Pfizer Inc. The majority were either Grade 1 (43.2

Subasumstat by Takeda Pharmaceutical for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

JANUARY 8, 2024

Subasumstat is under clinical development by Takeda Pharmaceutical and currently in Phase II for Relapsed Multiple Myeloma.

Subasumstat by Takeda Pharmaceutical for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

JANUARY 8, 2024

Subasumstat is under clinical development by Takeda Pharmaceutical and currently in Phase II for Relapsed Multiple Myeloma.

MHRA grants marketing authorisation for Oncopeptides’ multiple myeloma drug

Pharmaceutical Technology

NOVEMBER 14, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Oncopeptides’ Pepaxti (melphalan flufenamide; melflufen) along with dexamethasone to treat multiple myeloma patients. Pepaxti provides clinical benefit to patients with triple class refractory disease.

Enzalutamide by Pfizer for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

DECEMBER 21, 2023

Enzalutamide is under clinical development by Pfizer and currently in Phase I for Relapsed Multiple Myeloma.

BCMA-GPRC5D CAR-T Cells by Guangzhou Bio-gene Technology for Refractory Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

SEPTEMBER 14, 2023

BCMA-GPRC5D CAR-T Cells is under clinical development by Guangzhou Bio-gene Technology and currently in Phase II for Refractory Multiple Myeloma.

Eftozanermin alfa by AbbVie for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

OCTOBER 27, 2023

Eftozanermin alfa is under clinical development by AbbVie and currently in Phase I for Relapsed Multiple Myeloma.

BCMA-GPRC5D CAR-T Cells by Guangzhou Bio-gene Technology for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

SEPTEMBER 14, 2023

BCMA-GPRC5D CAR-T Cells is under clinical development by Guangzhou Bio-gene Technology and currently in Phase II for Relapsed Multiple Myeloma.

Blackstone funds new trials of Sanofi’s Sarclisa in myeloma

pharmaphorum

MARCH 15, 2022

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 myeloma, accelerating its development. The post Blackstone funds new trials of Sanofi’s Sarclisa in myeloma appeared first on.

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

pharmaphorum

MAY 25, 2021

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) congress, which kicks off in a few days’ time. billion myeloma blockbuster Darzalex (daratumumab). billion myeloma blockbuster Darzalex (daratumumab).

InnoCare announced first subject dosed in clinical trial of novel targeted protein degrader ICP-490

Pharmafile

APRIL 4, 2023

InnoCare has announced that the first subject has been dosed in its clinical trial of its novel targeted protein degrader ICP-490 in China. The company focuses on the treatment of cancer and autoimmune diseases, with this candidate aiming to treat multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL). read more

Communication

Alternative immunotherapies improve relapsed myeloma survival

European Pharmaceutical Review

NOVEMBER 7, 2022

The findings will serve as a benchmark for future prospective clinical studies that intend to improve the outcomes of patients who progress after CAR-T.”. “The The findings will serve as a benchmark for future prospective clinical studies that intend to improve the outcomes of patients who progress after CAR-T.”.

Immunity

Immunity Immunization

Optimizing Clinical Pathways and Analyzing Quality of Life for Patients with MM

Pharmacy Times

JULY 21, 2023

Multiple myeloma clinical pathways and factors affecting patient quality of life are explored by an expert panel.

Trial sets up earlier use of J&J’s Carvykti in myeloma

pharmaphorum

JANUARY 29, 2023

One of the Johnson & Johnson’s top clinical trial readouts for 2023 just generated results, which bode very well for the future prospects of multiple myeloma CAR-T Carvykti. The post Trial sets up earlier use of J&J’s Carvykti in myeloma appeared first on.

FDA clears IND for Gracell Biotechnologies’ phase 1 clinical trial for multiple myeloma treatment

STAT+: FDA advisers back CAR-T therapies in blood cancer, despite safety concerns

Trending Sources

STAT+: A CAR-T from Bristol Myers benefits myeloma patients at earlier stage of care

STAT+: What to make of Gilead’s Trodelvy troubles and Elevation Oncology’s surprising rise

Molecular Templates Reports the US FDA's Clinical Hold on P-I Study of MT-0169 for Relapsed Multiple Myeloma

Heidelberg Pharma gains FDA ODD for ATAC candidate

Multiple myeloma bispecific antibody granted accelerated approval

Preventative approach could reduce immunotherapy side effects

BCMA-GPRC5D CAR-T Cells by Guangzhou Bio-gene Technology for Relapsed Multiple Myeloma: Likelihood of Approval

FDA grants orphan drug status to Poseida’s multiple myeloma therapy

GEN-3014 by Genmab for Relapsed Multiple Myeloma: Likelihood of Approval

STAT+: Pharmalittle: GSK pulls a key blood-cancer drug off the market; Teva picks a new CEO

FDA Grants Priority Review to Novel Bispecific Antibody for Multiple Myeloma

FDA APPROVES BMS AND J&J CAR-T CELL THERAPIES FOR THE EARLIER TREATMENT OF MULTIPLE MYELOMA

Minimizing Terms in Multiple Myeloma Clinical Trials May Inaccurately Reflect Tolerability, Rates of AEs

CHMP meeting highlights: February 2024

NICE recommends all-oral treatment for multiple myeloma

Glenmark and Ichnos launch Ichnos Glenmark Innovation to accelerate new drug discovery in cancer treatment

Assessing Clinical Trial Efficacy vs Real-World Effectiveness in the Management of Multiple Myeloma

EMA CHMP provides positive opinion for Janssen’s multiple myeloma therapy

NICE publishes draft nod for Darzalex combo to treat multiple myeloma

GSK will pull Blenrep from US market after failed trial

FDA Accepts Priority Review for Linvoseltamab to Treat Adult Patients With R/R MM

New blood cancer treatment appears successful for most trial patients

Eftozanermin alfa by AbbVie for Refractory Multiple Myeloma: Likelihood of Approval

FDA committee recommends BMS-2seventy’s Abecma

BCMA-GPRC5D CAR-T Cells by Guangzhou Bio-gene Technology for Refractory Multiple Myeloma: Likelihood of Approval

Assessing Clinical Trial Efficacy Vs Real-World Effectiveness in the Treatment of Multiple Myeloma

Kite and Arcellx enter partnership for multiple myeloma therapy development

GEN-3014 by Genmab for Refractory Multiple Myeloma: Likelihood of Approval

Breakthrough Therapy Designation for Pfizer bispecific antibody

Subasumstat by Takeda Pharmaceutical for Relapsed Multiple Myeloma: Likelihood of Approval

Subasumstat by Takeda Pharmaceutical for Relapsed Multiple Myeloma: Likelihood of Approval

MHRA grants marketing authorisation for Oncopeptides’ multiple myeloma drug

Enzalutamide by Pfizer for Relapsed Multiple Myeloma: Likelihood of Approval

BCMA-GPRC5D CAR-T Cells by Guangzhou Bio-gene Technology for Refractory Multiple Myeloma: Likelihood of Approval

Eftozanermin alfa by AbbVie for Relapsed Multiple Myeloma: Likelihood of Approval

BCMA-GPRC5D CAR-T Cells by Guangzhou Bio-gene Technology for Relapsed Multiple Myeloma: Likelihood of Approval

Blackstone funds new trials of Sanofi’s Sarclisa in myeloma

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

InnoCare announced first subject dosed in clinical trial of novel targeted protein degrader ICP-490

Alternative immunotherapies improve relapsed myeloma survival

Optimizing Clinical Pathways and Analyzing Quality of Life for Patients with MM

Trial sets up earlier use of J&J’s Carvykti in myeloma

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