Davy James

Approval of Breyanzi (lisocabtagene maraleucel) to treat adults with relapsed or refractory mantle cell lymphoma was based on findings from the open-label, multicenter, pivotal TRANSCEND NHL 001 trial.

Dupixent (dupilumab) was previously granted priority review status as an add-on maintenance treatment for certain adults with uncontrolled chronic obstructive pulmonary disease.

Patients with locally advanced or metastatic non-small cell lung cancer who were previously administered at least one line of therapy showed superior overall survival compared to docetaxel.

Sarclisa (isatuximab-irfc) could become the first anti-CD38 therapy indicated in combination with bortezomib, lenalidomide, and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for a transplant.

Keytruda (pembrolizumab; Merck) plus chemotherapy administered as neoadjuvant treatment and then as monotherapy postsurgery produced a statistically significant improvement in overall survival in patients with high-risk early-stage triple-negative breast cancer.

Sotyktu (deucravacitinib; Bristol Myers Squibb) is an oral, selective, allosteric tyrosine kinase 2 inhibitor that produced clinically meaningful improvements in Psoriasis Area and Severity Index scores among adult patients with moderate-to-severe plaque psoriasis.

Once-weekly subcutaneous injection of CT-388 produced significant weight loss in healthy adults with obesity compared with placebo across 24 weeks in an early phase trial.

Leqembi (lecanemab-irmb) was previously granted fast track designation by the FDA for a subcutaneous version of the drug to treat Alzheimer disease in patients with mild cognitive impairment or the mild dementia stage of the disease.

In the Complete Response Letter to Dynavax, the FDA stated that the supplemental Biologic License Application based on findings from the Phase I HBV-24 trial lacked sufficient data to support a full evaluation of the efficacy or safety of a four-dose Heplisav-B regimen in adults on hemodialysis.

Trial data met the pre-specified futility criteria for the primary endpoint of recurrence-free survival with the combination of vibostolimab and Keytruda (pembrolizumab) in the adjuvant treatment of patients with resected high-risk melanoma.

Administrative constraints cause FDA to push back its review of data from a pivotal Phase III trial (NCT05127434), which demonstrated favorable clinical safety and efficacy for mRNA-1345, an investigational vaccine found to reduce the incidence of RSV-associated lower respiratory tract disease.

Findings from the Phase III KEYNOTE-B21 trial show that Keytruda (pembrolizumab) plus chemotherapy as adjuvant therapy, with or without radiotherapy, administered to patients with newly diagnosed high-risk endometrial cancer following surgery with curative intent did not achieve superiority in disease-free survival over placebo.

Cell-selective, adeno-associated virus gene therapy DB-OTO restored hearing to normal levels within 24 weeks in a child born with profound genetic deafness due to variants of the otoferlin gene.

Phase I/IIa HORNBILL trial results show Boehringer Ingelheim’s novel humanized monoclonal anti-Sema3A antibody was well tolerated and showed early signs of efficacy.

Johnson & Johnson’s novel targeted therapy TAR-200 produced a greater than 80% complete response rate in patients with Bacillus Calmette-Guérin–unresponsive, high-risk non–muscle-invasive bladder cancer with carcinoma in situ.

The combination of Calquence (acalabrutinib; AstraZeneca) plus bendamustine and rituximab generated a clinically meaningful improvement in progression-free survival in the first-line treatment of adults with mantle cell lymphoma.

Phase III KEYNOTE-811 trial data show Keytruda (pembrolizumab) combined with trastuzumab and chemotherapy achieved the primary endpoint of overall survival in the first-line treatment of patients with HER2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Data from the Phase III STRIDE-10 trial showed V116 produced immune responses against the serotypes responsible for the majority of adult invasive pneumococcal disease.

Enhertu, a HER2-directed antibody-drug conjugate, showed a clinically meaningful survival benefit in progression-free survival among patients with HR-positive, HER2-low metastatic breast cancer.

Phase II/III COMPANION-002 trial shows promise of CTX-009 in combination with paclitaxel for patients with metastatic or locally advanced biliary tract cancer.

Rinvoq (upadacitinib) shows efficacy in both itch resolution and skin clearance in the treatment of patients with atopic dermatitis.

Data from part one of the Phase III RUBY trial show Jemperli (dostarlimab) plus chemotherapy produced a statistically significant and clinically meaningful survival benefit in patients with primary advanced or recurrent endometrial cancer, including those with mismatch repair proficient/microsatellite stable tumors.

Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.

Morbidity and Mortality Weekly Report finds that the original monovalent COVID-19 vaccines were associated with fewer hospitalizations, particularly within the first four months after vaccination, but the duration of protection from the original vaccine diminished over time.

Meta-analysis shows neoadjuvant immune checkpoint inhibitors with chemotherapy improves two-year event-free survival and pathologic complete response in patients with early-stage non–small cell lung cancer.

Data from an open-label extension study show that administration of first-line Kesimpta for up to six years in treatment-naïve patients recently diagnosed with relapsing multiple sclerosis led to fewer relapses, suppressed MRI lesion activity, and fewer disability worsening events.

Phase III SURMOUNT-OSA trial data shows promise of tirzepatide, marketed as Zepbound and Mounjaro, treating the underlying disease in patients with moderate-to-severe obstructive sleep apnea.

Imfinzi (durvalumab; AstraZeneca) plus gemcitabine and cisplatin was found to double the overall survival rate after three years in patients with advanced biliary tract cancer.

Columvi with gemcitabine and oxaliplatin showed the potential to improve survival in patients with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for autologous stem cell transplant.

Multicenter, open-label, 156-week extension trial finds that Qulipta (atogepant) reduced migraine days and acute medication use in patients with chronic or episodic migraine.