Saturday, September 7, 2019

Orphan drug status to CT053- Multiple myeloma

The FDA has given orphan drug status to CT053, an investigational chimeric antigen receptor T-cell therapy for the treatment of multiple myeloma.
CT053 (CARsgen Therapeutics) is an autologous, fully human CAR T-cell therapy that targets the B-cell maturation antigen on the surface of cancer cells.
CARsgen’s CT053 is one of the company’s three CAR T-cell products approved for early-stage clinical trials. The others include humanized CD19 CAR-T for B-cell leukemia and lymphoma and GPC3 CAR-T for hepatocellular carcinoma and non-small cell lung cancer.
“FDA orphan designation is an important regulatory milestone in the continued development and commercialization of CT053 anti-BCMA CAR-T cells,” Zonghai Li, MD, PhD, founder, CEO and chief scientific officer of CARsgen said in a press release.
Li added that CT053 showed “outstanding potency” during an exploratory phase 1 clinical study in China, where 19 of 24 patients with relapsed or refractory multiple myeloma had a complete response to therapy. In addition, there were no cases of high-grade (3 or 4) cytokine release syndrome during the study.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.

Tuesday, August 27, 2019

Recent Trends in Hematology & Oncology

Trials show that adding pembrolizumab to standard therapy failed to improve clinical outcomes for untreated or relapsed/refractory multiple myeloma. Explore more hemato-oncology at:

Recent Trends in Hematology & Oncology

Trials show that nivolumab in combination with brentuximab vedotin induced high antitumor activity for relapsed or refractory primary mediastinal B-cell lymphoma. Explore more hemonc at:

Wednesday, August 21, 2019

Recent Trends in Hematology/ Oncology

Research shows that combination of humanized anti-CD19 and anti-B-cell maturation antigen chimeric antigen receptor T-cells shows activity for relapsed or refractory multiple myeloma. Explore more hemonc at:  

Monday, August 19, 2019

World Hematology 2020

Pulsus Group is glad to announce the 2020 conference in the Hematology and Oncology series, the 12th World Hematology and Oncology Congress, scheduled to be held on March 2- 3, 2020 at Edinburgh, Scotland around the theme “Unravelling the enigmas in hematology & oncology”. We cordially invite all to join us at the event to explore every single aspect of hematology & oncology. Get to know more details at: World Hematology 2020

Monday, July 1, 2019

FDA approval of daratumumab for Multiple Myeloma

The Food and Drug Administration (FDA) announced their approval of daratumumab in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant.

“Today’s approval of DARZALEX (daratumumab) underscores the significant clinical benefit of this CD38 monoclonal antibody and our efforts to advance treatment paradigms to change the course of the disease,” said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC in a press release. “Importantly, this milestone also highlights the efficiency of the FDA’s Real-Time Oncology Review process, ensuring that proven treatment regimens, such as DARZALEX plus lenalidomide and dexamethasone, are made available to patients as soon as possible.”
The decision for approval was made based on results of MAIA, an open-label, randomized (1:1) phase III study comparing dartumumab (16 mg/kg) in combination with lenalidomide and low-dose dexamethasone (DRd) to lenalidomide and low-dose dexamethasone (Rd), in 737 patients.
The trial showed an improvement in progression-free survival (PFS) with DRd compared with Rd. The median PFS had not been reached in the DRd arm and was 31.9 months in the Rd arm (HR 0.56; 95% CI: 0.43, 0.73; p<0.0001). The median time to response was 1.05 months (range: 0.2 to 12.1 months) in the DRd group and 1.05 months (range: 0.3 to 15.3 months) in the Rd group. The median response duration had not been reached in the DRd group and was 34.7 months (95% CI: 30.8, not estimable) in the Rd group.
In the DRd arm, the most frequent (≥20%) adverse reactions were infusion reactions, diarrhea, constipation, nausea, peripheral edema, fatigue, back pain, asthenia, pyrexia, upper respiratory tract infection, bronchitis, pneumonia, decreased appetite, muscle spasms, peripheral sensory neuropathy, dyspnea and cough.
Daratumumab can cause severe and/or serious infusion reactions, including anaphylactic-related ones. Patients should be pre‑medicated with antihistamines, antipyretics and corticosteroids and frequently monitored during the entire infusion. The recommended daratumumab dose is 16 mg/kg actual body weight. 
Get to know more about Hematology & Oncology at World Hematology