Caroline Seymour

The FDA has accepted the filing of an ANDA for Lutetium Lu 177 Dotatate indicated for patients with gastroenteropancreatic neuroendocrine tumors.

The FDA has issued a CRL to the zolbetuximab BLA for patients with HER2- gastric or GEJ junction adenocarcinoma whose tumors are Claudin18.2 positive.

Significant tumor necrosis greater than 70% occurred in 3 patients with resectable hepatocellular carcinoma following neoadjuvant treatment with low-dose stereotactic body radiation therapy and cemiplimab-rwlc and adjuvant cemiplimab.

A biologics license application seeking the approval of the investigational positron emission tomography imaging agent 89Zr-DFO-girentuximab in clear cell renal cell carcinoma has been submitted to the FDA.

The phase 3 RELATIVITY-123 trial evaluating the fixed-dose combination of nivolumab and relatlimab in patients with microsatellite stable metastatic colorectal cancer will be discontinued due to futility.

David P. Carbone, MD, PhD, sought to transform lung cancer care and did it—but didn’t anticipate the personal journey it would put him on.

Findings from the EV-302 trial presented at the 2023 ESMO Congress revealed that the combination of enfortumab vedotin and pembrolizumab may become the preferred frontline standard of care for patients with locally advanced or metastatic urothelial cancer regardless of cisplatin eligibility.

The FDA has approved label updates for zanubrutinib to include data from the ALPINE trial in relapsed/refractory chronic lymphocytic leukemia, and axicabtagene ciloleucel to include findings from the primary overall survival analysis of the ZUMA-7 trial in relapsed/refractory large B-cell lymphoma.

A supplemental biologics license application and new drug application seeking the approval of amivantamab plus lazertinib as frontline therapy for the treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations have been submitted to the FDA.

The FDA has approved enfortumab vedotin in combination with pembrolizumab for patients with locally advanced or metastatic urothelial cancer.

The combination of pembrolizumab and lenvatinib failed to produce a statistically significant improvement in progression-free survival and overall survival vs platinum-based chemotherapy with carboplatin and paclitaxel as frontline therapy in patients with advanced or recurrent endometrial cancer whose disease in mismatch repair proficient/not microsatellite instability–high or mismatch repair deficient.

The FDA has approved belzutifan (Welireg) for the treatment of patients with advanced renal cell carcinoma (RCC) following a PD-1 or PD-L1 inhibitor and a VEGF TKI.

Idecabtagene vicleucel has received marketing and manufacturing approval in Japan for its supplemental new drug application in patients with relapsed/refractory multiple myeloma who have received at least 2 prior lines of therapy.

The FDA has accepted and granted priority review to the biologics license application seeking the approval of tarlatamab for the treatment of patients with advanced small cell lung cancer.

DZD8586 showcased antitumor activity and favorable safety with limited grade 3 or greater treatment-emergent adverse effects in patients with heavily pretreated B-cell non-Hodgkin lymphoma, according to preliminary findings from a pooled analysis of two ongoing phase 1 trials.

OncLive® will be LIVE with OncLive® News Network: On Location at the 2023 ASH Annual Meeting. Each day, we will broadcast a series of interviews with top thought leaders, to learn their thoughts and reactions to data presented across oncology during the conference.

Induction therapy with subcutaneous daratumumab followed by autologous stem cell transplant, daratumumab, bortezomib, lenalidomide, and dexamethasone consolidation and daratumumab/lenalidomide maintenance prolonged progression-free survival in patients with newly diagnosed, transplant-eligible multiple myeloma.

OncLive® will be LIVE with OncLive® News Network: On Location at the 2023 ASH Annual Meeting. Each day, we will broadcast a series of interviews with top thought leaders, to learn their thoughts and reactions to data presented across oncology during the conference.

OncLive® will be LIVE with OncLive® News Network: On Location at the 2023 ASH Annual Meeting. Each day, we will broadcast a series of interviews with top thought leaders, to learn their thoughts and reactions to data presented across oncology during the conference.

Ibrutinib plus venetoclax, given at a duration determined by minimal residual disease, improved progression-free survival and overall survival vs fludarabine, cyclophosphamide, and rituximab in patients with treatment-naive chronic lymphocytic leukemia.

The use of Orca-T with myeloablative chemotherapy conditioning had comparable safety and efficacy in younger and older patients with hematologic malignancies, according to data from a phase 1b study.

Treatment with an all-oral regimen of arsenic trioxide, all-trans retinoic acid, and ascorbic acid led to both 3-year overall survival and relapse-free survival rates of 97% in patients with acute promyelocytic leukemia.

Neoadjuvant nivolumab and non–anthracycline containing chemotherapy produced promising pathologic complete response rates regardless of whether nivolumab was administered before or during treatment with carboplatin and paclitaxel in patients with stage I to IIB triple-negative breast cancer.

The combination of nivolumab and ipilimumab led to a statistically significant and clinically meaningful improvement in progression-free survival per blinded independent central review compared with investigator’s choice of chemotherapy as frontline therapy in patients with metastatic colorectal cancer.

The FDA has granted an accelerated approval to pirtobrutinib for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL2 inhibitor.

The FDA has granted priority review to a supplemental biologics license application for enfortumab vedotin plus pembrolizumab for the frontline treatment of patients with locally advanced or metastatic urothelial cancer.

The FDA has granted fast track designation to zotatifin for use in combination with fulvestrant and abemaciclib as second- or third-line therapy for the treatment of patients with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer with disease progression following treatment with endocrine therapy and a CDK4/6 inhibitor.

Nadofaragene firadenovec-vncg led to encouraging rates of high-grade recurrence-free survival and overall survival in patients with high-risk, BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.

Telisotuzumab vedotin produced meaningful response rates and other clinically relevant outcomes in patients with c-Met protein overexpressed, EGFR wild-type, advanced or metastatic nonsquamous non–small cell lung cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of subcutaneous atezolizumab for all indications in which the intravenous formulation is approved, including certain types of lung, liver, bladder, and breast cancer