Category: Breakthrough Therapy Designation

• The BTD is based on P-II CITYSCAPE study assessing Tiragolumab + Tecentriq vs Tecentriq + PBO as a 1L treatment of 135 patients in a ratio (1:1) with LA unresectable metastatic NSCLC whose tumors have high PD-L1 expression with no EGFR
• Result: improvement in ORR (37% vs 21%); reduction in the risk of disease worsening or death (42%); ORR (66% vs 24%); m-PFS (not reached vs 4.11 mos.); Grade 3 AEs (48% vs. 44%)
• Tiragolumab is a mAb designed to bind with TIGIT and works as an immune amplifier, by potentially enhancing the body’s immune response. The company is evaluating the tiragolumab across various settings in different tumor types, including lung, esophageal and cervical cancers

Click here ­to­ read full press release/ article | Ref: BusinessWire | Image: Magic Number IP

The post Genentech’s Tiragolumab + Tecentriq Receive the US FDA’s Breakthrough Therapy Designation for PD-L1-High Non-Small Cell Lung Cancer first appeared on PharmaShots.

• The BT (breakthrough therapy) Designation was based on initial data for ongoing single-arm, open-label, non-randomized, dose-escalation, P-I study for safety and efficacy in B-ALL
• The BT Designation procedure is under NMPA’s revised Drug Registration Regulation with effect from Jul 1, 2020. It is designed to expedite the development of treatment of diseases with no existing treatment and evidence indicates the benefit of the therapy vs available treatment
• CNCT19 targets CD19 is a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CNCT19 is currently being developed by Casi and Juventas Cell Therapy

Click here ­to­ read full press release/ article | Ref: Casi Pharmaceuticals  | Image: Casi Pharmaceuticals

The post Casi and Juventas Cell Therapy’s CNCT19 (CD19 CAR-T) Receives China NMPA’s BT Designation for Relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL) first appeared on PharmaShots.

• The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in patients with advanced NSCLC with KRAS G12C mutation whose cancer had progressed despite prior treatment with CT and/or immunotherapy
• The company is currently recruiting in a P-III study (CodeBreaK 200) assessing sotorasib vs docetaxel in patients with KRAS G12C-mutated NSCLC. Amgen has several P-Ib combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment
• Sotorasib has also accepted into FDA’s Real-Time Oncology Review Pilot Program. Additionally, the company plans to submit the NDA to the US FDA by the end of 2020

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: BioSpace

The post Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for Advanced or Metastatic NSCLC with KRAS G12C Mutation first appeared on PharmaShots.

Shots:

• The BT destination follows P-lll DAPA-CKD assessing Farxiga (10mg, qd) + SOC vs PBO in 4,304 patients with CKD Stages 2-4 and elevated urinary albumin excretion, with/ out T2D across 21 countries
• Results: 39% reduction in the composite measure of worsening of renal function or risk of CV or renal death; 31% reduction in death from any cause
• Farxiga (PO, qd) is an SGLT2 inhibitor indicated in adults for the treatment of insufficiently controlled T2D as both monothx. and combination therapy as an adjunct to diet and exercise to improve glycemic control, weight loss, and BP reduction

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: DW

Related News: AstraZeneca Reports Results of Farxiga (dapagliflozin) in P-III DAPA-CKD Trial for Patients With and Without Type-2 Diabetes

The post AstraZeneca’s Farxiga Receives the US FDA’s Breakthrough Therapy Designation for Chronic Kidney Disease first appeared on PharmaShots.

Shots:

• The BT designation is based on the final analysis of the Pevonedistat-2001 P-II study assessing pevonedistat + azacitidine vs azacitidine as monothx. in patients with rare leukemias, including HR-MDS
• The 1EPs of the study include OS, EFS, CR and transfusion independence, and AE profile. The designation addresses the needs of people living with HR-MDS, for whom few therapies exist, and the benefits are limited
• Pevonedistat is a first in class NEDD8-activating enzyme (NAE) inhibitor. The pre-clinical studies demonstrated the inhibition of NAE, blocked the modification of select proteins, which resulted in the disruption of cell cycle progression and cell survival, leading to cancer cell death

Click here ­to­ read full press release/ article | Ref: Takeda | Image: Future Medicine India

Shots:

• The designation is based on P-II study evaluating MK-6482 in patients with VHL-associated RCC with nonmetastatic RCC tumors >3cms in size, unless immediate surgery is required
• The FDA’s BT designation is granted to expedite the development and review of medicines that are intended to treat serious or life-threatening conditions and have demonstrated preliminary clinical evidence indicating that the medicine may provide a substantial improvement over available therapy on at least one clinically significant endpoint
• MK-6482 (formerly PT2977) is an investigational oral HIF-2α inhibitor, currently being evaluated in a P-III  trial in advanced RCC (NCT04195750), a P-II trial in VHL-associated RCC (NCT03401788), and a P-I/II dose-escalation and dose-expansion trial in advanced solid tumors, including advanced RCC (NCT02974738)

Click here ­to­ read full press release/ article | Ref: Merck | Image: Market Watch