Chris Ryan

Articles

FDA Grants Priority Review to Ivosidenib for IDH1+ Relapsed/Refractory MDS

August 15th 2023

The FDA has granted priority review to the supplemental new drug application seeking the approval of ivosidenib for the treatment of patients with IDH1-mutated, relapsed/refractory myelodysplastic syndrome.

FDA Lifts Clinical Hold on BCMA-Directed Modified CAR T-Cell Therapy in Multiple Myeloma

August 15th 2023

The FDA has lifted the partial clinical hold placed on the clinical program evaluating the investigational new drug, CART-ddBCMA, in the treatment of patients with relapsed/refractory multiple myeloma.

FDA Places Clinical Hold on Phase 1 Trial of SC-DARIC33 in Pediatric R/R CD33+ AML

August 14th 2023

The FDA has placed a clinical hold on the phase 1 PLAT-08 trial evaluating SC-DARIC33 in pediatric and young-adult patients with relapsed/refractory CD33-positive acute myeloid leukemia.

BAT8006 Elicits Disease Control, Safety in Advanced Ovarian Cancer and Other Solid Tumors

August 14th 2023

Treatment with the folate receptor–α antibody-drug conjugate BAT8006 led to responses with a manageable safety profile in patients with advanced solid tumors, including ovarian cancer, breast cancer, and cervical cancer.

Teclistamab Plus Nirogacestat Elicits Durable Responses in Relapsed/Refractory Myeloma

August 11th 2023

The combination of teclistamab and nirogacestat produced high and deep responses in patients with relapsed/refractory multiple myeloma.

BDC-1001 Monotherapy Under Further Evaluation in Phase 2 Trial in HER2+ Cancers

August 11th 2023

The first patients have been dosed in the phase 2 portion of a phase 1/2 trial evaluating BDC-1001 monotherapy in patients with HER2-positive colorectal cancer, endometrial cancer, and gastroesophageal cancer.

Glecirasib Receives Breakthrough Therapy Designation in China for KRAS G12C–Mutated Pancreatic Cancer

August 10th 2023

China’s Center for Drug Evaluation of the National Medical Products Administration has granted a breakthrough therapy designation to glecirasib for the treatment of patients with pancreatic cancer harboring a KRAS G12C mutation and who have progressed after frontline standard-of-care treatment.

Lack of Clinical Benefit Leads to End of Development for Etrumadenant in mCRPC

August 10th 2023

The development of etrumadenant as a potential treatment option for patients with metastatic castration-resistant prostate cancer will be discontinued after data from the phase 1/2 ARC-6 trial did not demonstrate a sufficient clinical benefit for etrumadenant plus zimberelimab and docetaxel compared with docetaxel alone.

FDA Approves Talquetamab for Relapsed/Refractory Multiple Myeloma

August 10th 2023

The FDA has granted accelerated approval to talquetamab-tgvs for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

FDA Issues CRL to NDA for Avasopasem in Radiotherapy-Induced Severe Oral Mucositis in Head and Neck Cancer

August 9th 2023

The FDA has issued a complete response letter to the new drug application seeking the approval of avasopasem manganese as a treatment for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment.

MDNA11 Generates Activity, Safety in Advanced Solid Tumors

August 9th 2023

Treatment with the long-acting interleukin-2 superkine led to durable tumor control and no dose-limiting toxicities in patients with advanced solid tumors, according to data from the dose-escalation portion of the phase 1/2 ABILITY-1 trial.

Cisplatin/Carboplatin Shortages Underscore Need for Strategies to Prevent Future Cancer Drug Disruptions

August 8th 2023

Balazs Halmos, MD, explains why a national effort is needed to mitigate current and future drug shortages in oncology and discusses strategies being used to navigate the current cisplatin and carboplatin shortages.

Camsirubicin Reduces Tumor Size in Advanced Soft Tissue Sarcoma

August 8th 2023

Treatment with camsirubicin led to a reduction in tumor size in patients with advanced soft tissue sarcoma.

FDA Grants Clearance for Phase 3 Study of Lisaftoclax in Previously Treated CLL/SLL

August 7th 2023

The FDA has granted clearance for a global, registrational, phase 3 study examining lisaftoclax in combination with a BTK inhibitor in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who received prior treatment with a BTK inhibitor.

Platinum Chemotherapy Shortages Create Additional Burden for Patients With Cancer

August 7th 2023

Jacob Sands, MD, discusses how the ongoing shortages of carboplatin and cisplatin have presented new challenges to patient care, how he and colleagues at Dana-Farber Cancer Institute are navigating these shortages, and how these limitations could ultimately have an impact on patients.

Neoadjuvant Pembrolizumab Plus Chemotherapy Improves pCR Rate in High-Risk, Early-Stage ER+/HER2– Breast Cancer

July 28th 2023

Neoadjuvant pembrolizumab plus chemotherapy led to an improvement in pathological complete response rate compared with chemotherapy plus placebo in patients with high-risk, early-stage, estrogen receptor–positive, HER2-negative breast cancer.

Sacituzumab Govitecan Wins Approval in Europe for Pretreated HR+/HER2– Metastatic Breast Cancer

July 28th 2023

The European Commission has approved sacituzumab govitecan-hziy for the treatment of adult patients with unresectable or metastatic hormone receptor–positive, HER2-negative breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the advanced setting

Long-Term Data Show Improved CR Rates for Cosibelimab in Advanced CSCC

July 28th 2023

Long-term data demonstrated that treatment with cosibelimab improved complete response rates over time in patients with locally advanced or metastatic cutaneous squamous cell carcinoma in a phase 1 trial.

EU Approves Piflufolastat (18F) PSMA PET Imaging Agent for Prostate Cancer

July 28th 2023

The European Commission has approved piflufolastat (18F) for the detection of prostate-specific membrane antigen–positive lesions with positron emission tomography in adults with prostate cancer.

UGN-102 Improves Survival, Elicits CRs in Low-Grade, Intermediate-Risk NMIBC

July 27th 2023

Treatment with UGN-102 with or without transurethral resection of bladder tumors led to an improvement in disease-free survival compared with TURBT alone in patients with low-grade, intermediate-risk non–muscle-invasive bladder cancer.