News

A decision on the supplemental new drug application of osimertinib in this population is expected in the fourth quarter of 2024.

In clinical trials, dostarlimab continues to show a 100% CR in dMMR rectal cancer, camrelizumab plus rivoceranib improved survival in untreated uHCC, lorlatinib provided durable PFS in ALK+ lung cancer. We also cover the acknowledged BLA for zolbetuximab and the meaningful PFS achieved with ibrutinib/venetoclax in CLL/SLL.

Manmeet Ahluwalia, MD, MBA, FASCO, discusses the takeaways from a study which examined the impact of various therapies, including combination treatments, for patients with metastatic renal cell carcinoma.

Mikkael A. Sekeres MD, MS, provides insight on the approval of imetelstat for treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia.

John Mascarenhas, MD, discusses phase 3 of the SENTRY study evaluating the efficacy and safety of selinexor plus ruxolitinib in patients with JAK inhibitor treatment-naive myelofibrosis.

Mazyar Shadman, discusses the mechanism of action of sonrotoclax and the phase 3 trial titled CELESTIAL-TNCLL, which is evaluating the agent for the treatment of patients with chronic lymphocytic leukemia.

In the final part of our 3-part series, a roster of developing antibody-drug conjugates gives clinicians and patients hope in hard-to-treat cancers.

The FDA approved imetelstat for treating patients with lower-risk myelodysplastic syndromes with transfusion-dependent anemia, regardless of ring sideroblast status.

Joseph Greer, PhD, discusses the late-breaking abstract from the 2024 ASCO Annual Meeting evaluating telehealth vs in-person palliative care for patients with advanced non-small cell lung cancer.

The combination therapy showed consistent benefits across various subgroups, including those with poor-risk disease and higher PD-L1 expression.

Here is a look back on all the FDA happenings from the month of May 2024.

The FDA granted fast track status to lunresertib and camonsertib for platinum-resistant ovarian cancer with specific mutations, currently being evaluated for safety and efficacy in the phase 1 MYTHIC trial, with results expected in late 2024.

Minesh Mehta, MD, discusses positive findings from the phase 3 METIS trial investigating TTFields therapy for brain metastases in NSCLC.

Topline findings from the phase 2 PICCOLO trial support the potential use of mirvetuximab soravtansine for the treatment of folate receptor alpha-positive, platinum-sensitive ovarian cancer.

Lynn Schuchter, MD, 2023-2024 ASCO president, discusses her top abstracts from the annual meeting.

Pending FDA review, TLX250-CDx awaits consideration following the successful outcomes of the phase 3 ZIRCON trial in clear cell renal cell carcinoma.

An international, multicenter, first-in-human, phase 1/2 study of PFL-002/VERT-002 plans to enroll patients with NSCLC with MET alterations and expects to begin patient enrollment by the end of 2024.

A high complete response rate was achieved in patients with BCG–unresponsive NMIBC using the combination of cretostimogene grenadenorepvec and pembrolizumab, according to final phase 2 CORE-001 trial results.

Lenvatinib plus pembrolizumab delivered a significant benefit in time to disease progression in all organs vs sunitinib in advanced renal cell carcinoma.

The FDA has cleared a phase 2/3 trial testing KPG-121, a novel drug, combined with abiraterone for first-line treatment of metastatic castration-resistant prostate cancer.

Prophylactic treatment with tocilizumab shows promise for reducing a serious adverse effect in multiple myeloma treatment.

Alexa Simon Meara, MD, discussed how rheumatology and oncology can work together to improve outcomes for patients undergoing immunotherapy treatment for cancer.

A promising new treatment option has emerged for patients with a specific type of gastrointestinal stromal tumor that has become resistant to standard therapy.

Yucai Wang, MD, PhD, discusses the rationale, methods, and design of a study evaluating the efficacy of pembrolizumab when given as both a monotherapy and in combination with B-cell receptor inhibitors for Richter transformation of CLL.

Frontline treatment with petosemtamab and pembrolizumab produced early clinical efficacy in patients with recurrent or metastatic head and neck squamous cell carcinoma.

The METIS trial of tumor treating fields for the treatment of brain metastases in patients with non–small cell lung cancer met its primary end point, showing a statistically significant improvement in time to intracranial progression.

The first safety run-in cohort of the MajesTEC-7 trial showed promising safety/efficacy results with teclistamab, daratumumab, and lenalidomide in newly diagnosed multiple myeloma.

The combination of nivolumab and ipilimumab with chemotherapy shows significant long-term survival benefits in metastatic NSCLC, irrespective of PD-L1 expression or histology, as per updated 5-year data.

The combination of the adenovirus CAN-2409 and valacyclovir with continued immune checkpoint inhibitor therapy demonstrated favorable tolerability and induced a positive immune response.

A daratumumab-VRd–based regimen boosted the rate of MRD-negativity in patients with newly diagnosed, transplant-eligible multiple myeloma.