Kristi Rosa

China’s National Medical Products Administration has approved trastuzumab deruxtecan monotherapy in adult patients with unresectable or metastatic HER2-low breast cancer who have previously received a systemic therapy in the metastatic setting or whose disease recurred during or within 6 months of adjuvant chemotherapy.

The European Commission has granted conditional marketing authorization to glofitamab for fixed-duration administration in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following 2 or more lines of systemic treatment.

The sequential combination of 6-thio-2’-deoxyguanosine and cemiplimab provided a progression-free survival benefit in the first 2 patients with advanced non–small cell lung cancer enrolled to the part A safety lead-in portion of the phase 2 THIO-101 trial.

China’s National Medical Products Administration has approved the new drug application for equecabtagene autoleucel for the treatment of adult patients with relapsed or refractory multiple myeloma who previously received 3 or more lines of therapy, including a proteasome inhibitor and an immunomodulatory drug.

The FDA has granted orphan drug designation to inobrodib for use as a potential therapeutic option in patients with multiple myeloma.

The FDA has granted orphan drug designation to padeliporfin vascular targeted photodynamic therapy for use as a potential therapeutic option in patients with locally advanced pancreatic cancer.

The combination of botensilimab and balstilimab elicited durable responses and provided overall survival benefits in patients with microsatellite stable metastatic colorectal cancer that is resistant to chemotherapy and/or immunotherapy.

huCART19-IL8 had acceptable safety and induced durable responses in patients with lymphoma who were refractory or relapsed following second-generation CD19-targeted CAR T-cell therapies, according to data from a first-in-human phase 1 trial.

The FDA has granted breakthrough therapy designation to zenocutuzumab for use as a potential therapeutic option in patients with advanced unresectable or metastatic NRG1 fusion–positive pancreatic cancer after disease progression on previous systemic therapy or who have no satisfactory alternative options available.

The FDA has granted fast track designation to the combination of quaratusugene ozeplasmid and atezolizumab as maintenance therapy in patients with extensive-stage small cell lung cancer whose disease did not progress after receiving initial standard treatment with atezolizumab and chemotherapy.

The National Medical Products Administration in China has accepted for review a new drug application seeking the approval of repotrectinib for use in adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer.

The combination of galinpepimut-S and nivolumab provided positive survival outcomes with an acceptable safety profile in patients with malignant pleural mesothelioma who were refractory to or relapsed after at least 1 line of standard treatment.

Epcoritamab elicited a confirmed overall response rate of 82% by independent review committee assessment in patients with relapsed or refractory follicular lymphoma who received 2 or more prior systemic treatments, which exceeded the prespecified threshold for efficacy in the phase 1/2 EPCORE NHL-1 trial.

Fixed-duration treatment with single-agent mosunetuzumab resulted in a high complete response rate by end of treatment in patients with relapsed or refractory follicular lymphoma, according to updated data from the phase 2 GO29781 trial.

The EMA's Committee for Medicinal Products for Human Use has adopted a positive opinion regarding sacituzumab govitecan-hziy monotherapy in select patients with unresectable or metastatic hormone receptor–positive, HER2-negative breast cancer.

The BrECADD combination had noninferior efficacy and superior tolerability compared with escalated BEACOPP in patients with advanced classical Hodgkin lymphoma, according to data from the phase 3 HD21 trial.

The FDA has granted regular approval to blinatumomab (Blincyto) for the treatment of adult and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia in first or second complete remission with minimal residual disease of at least 0.1%

A new drug application seeking the approval of imetelstat for use as a therapeutic option for transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndrome who have not responded to, lost response to, or were not candidates for erythropoiesis-stimulating agents has been submitted to the FDA.

The FDA has approved talazoparib (Talzenna) plus enzalutamide (Xtandi) for use in patients with homologous recombination repair gene–mutated metastatic castration-resistant prostate cancer.

A single administration of lisocabtagene maraleucel provided deep and durable remissions when used as third-line treatment in patients with relapsed or refractory follicular lymphoma, including those with high-risk features.

The addition of pembrolizumab to trastuzumab and chemotherapy improved progression-free survival over trastuzumab and chemotherapy alone when used as a frontline regimen in patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

The FDA has extended the review period for the new drug application seeking the approval of momelotinib as a potential therapeutic option in patients with myelofibrosis.

The FDA has approved FoundationOne CDx for use as a companion diagnostic to determine patients with BRAF V600E–mutated metastatic colorectal cancer who may be candidates to receive encorafenib in combination with cetuximab.

Although the event rate did reach the expected level and longer follow-up is needed to adequately assess long-term toxicities, data from the phase 3 IELSG37 trial support the omission of radiotherapy in patients with primary mediastinal large B-cell lymphoma who achieve a complete metabolic response following chemoimmunotherapy.

The combination of daratumumab plus bortezomib, cyclophosphamide, and dexamethasone, elicited a complete response (CR) rate of 40% and a CR or better rate of 43% in patients with multiple myeloma presenting with extramedullary disease.

The FDA has removed a partial clinical hold that had been placed on a phase 1 trial investigating the safety and efficacy of MT-0169 as a potential therapeutic option in patients with relapsed or refractory multiple myeloma or non-Hodgkin lymphoma.

The FDA has accepted for review a supplemental biologics license application seeking the approval of pembrolizumab plus standard chemotherapy comprised of gemcitabine and cisplatin for use in patients with locally advanced unresectable or metastatic biliary tract cancer.

The addition of durvalumab to standard neoadjuvant chemotherapy significantly improved pathologic complete response over neoadjuvant chemotherapy alone in patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers.

The FDA has extended the Prescription Drug User Fee Act decision date by 3 months to allow more time to complete their review of the new drug application seeking the approval of nirogacestat in the treatment of adult patients with desmoid tumors.

A supplemental biologics license application seeking the approval of ciltacabtagene autoleucel for use in adult patients with relapsed and lenalidomide-refractory multiple myeloma who have previously received at least 1 line of therapy, including a proteasome inhibitor and an immunomodulatory agent, has been submitted to the FDA.