Kristi Rosa

A CRL has been issued by the FDA to the biologics license application seeking approval of linvoseltamab to treat some patients with multiple myeloma.

Bintrafusp alfa induced responses in recurrent/metastatic cervical cancer, supporting the need for further research into TGF-β-targeted therapies.

Treatment with pembrolizumab and chemotherapy for head and neck squamous cell carcinoma provided responses with a manageable safety profile.

Atezolizumab was safe and effective when administered before and following chemoradiation in unresectable stage III non–small cell lung cancer.

Treatment with paxalisib in patients with newly diagnosed unmethylated glioblastoma was well tolerated with no new safety signals.

Darzalex Faspro plus VRd was approved by the FDA for induction and consolidation in newly diagnosed multiple myeloma eligible for ASCT.

An accelerated approval has been granted by the FDA to epcoritamab-bysp (Epkinly) for adult patients with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy.

Glofitamab-gxbm plus gemcitabine and oxaliplatin significantly improved survival in relapsed/refractory diffuse large B-cell lymphoma not eligible for autologous stem cell transplant.

The FDA approved blinatumomab for patients 1 month or older with CD19-positive, Philadelphia chromosome–negative, B-cell precursor acute lymphoblastic leukemia.

Compared with fulvestrant alone, abemaciclib plus fulvestrant improved progression-free survival in select patients with hormone receptor–positive/HER2-negative advanced breast cancer.

Treatment with fuzuloparib, either with or without apatinib, provided superior progression-free survival benefit compared with chemotherapy in HER2– metastatic breast cancer with germline BRCA1/2 mutations.

The FDA granted an approval to imetelstat for certain patients with low- to intermediate-1-risk MDS who have transfusion-dependent anemia.

The survival benefit obtained from consolidation treatment with durvalumab after concurrent chemoradiation may change the standard of care for limited-stage small cell lung cancer.

Updated data from the MANIFEST-2 study support a paradigm shift in the treatment of JAK inhibitor–naive patients with myelofibrosis.

Compared with chemotherapy alone, atezolizumab plus chemotherapy did not improve overall survival in select patients with early relapsing triple-negative breast cancer.

The BLA for zenocutuzumab to treat NRG1-positive non–small cell lung cancer and pancreatic cancer received priority review from the FDA.

Cilta-cel (ciltacabtagene autoleucel; Carvykti) was approved by the FDA to treat patients with relapsed or refractory multiple myeloma who have previously received at least one line of therapy.

Accelerated approval has been granted by the FDA to lisocabtagene maraleucel for the treatment of certain patients with relapsed/refractory CLL or SLL.

Tislelizumab-jsgr (Tevimbra) has been approved for unresectable or metastatic esophageal squamous cell carcinoma (ESCC) among adult patients who have previously received systemic chemotherapy that did not include a PD-1/PD-L1 inhibitor.

In a 16-to-2 vote, the FDA's Medical Imaging Drugs Advisory Committee voted in support of the benefit-risk profile of Lumisight to detect cancerous tissue during breast conservation surgery.

An orphan drug designation has been granted by the FDA to ocifisertib as a potential treatment option in acute myeloid leukemia.

Treatment with neoadjuvant tislelizumab plus platinum-based doublet chemotherapy, followed by surgery and adjuvant tislelizumab, improved event-free survival in patients with resectable non–small cell lung cancer.

Patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with lisocabtagene maraleucel experienced durable responses.

Fast track designation has been granted by the FDA to vepdegestrant for the treatment of select patients with ER-positive/HER2-negative locally advanced or metastatic breast cancer.

Patients with advanced gastric cancer treated with second-line fruquintinib/paclitaxel experienced significant improvements in progression-free survival but not overall survival when compared with paclitaxel alone.

The FDA granted efineptakin alfa an orphan drug designation, deeming it a potential treatment option for pancreatic cancer.

An sNDA seeking approval for alectinib received priority review from the FDA, which, if approved, will be indicated to treat patients with early-stage ALK-positive NSCLC after surgery.

Patients with cisplatin-ineligible urothelial carcinoma treated with frontline pembrolizumab plus cabozantinib obtained responses with a manageable toxicity profile.

Patients with resectable gastric and GEJ cancers, regardless of region, experienced an improved pathologic complete response to treatment with durvalumab plus neoadjuvant FLOT compared with chemotherapy alone.

A breakthrough therapy designation has been granted by the FDA to TAR-200 for the treatment of Bacillus Calmette-Guérin–unresponsive, high-risk non–muscle invasive bladder cancer who are not eligible for or opted not to receive radical cystectomy.