Regeneron's BLA for odronextamab | Dr Cristina K Chang Meet at Bio San Diego posted on the topic | LinkedIn (2024)

Regeneron Pharmaceuticals, Inc.has announced that theU.S. Food and Drug Administration issued Complete Response Letters (CRLs) for the Biologics License Application for bispecific antibody odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy. The only approvability issue is related to the enrollment status of the confirmatory trials. The CRLs – one for R/R FL and one for R/R DLBCL – did not identify any approvability issues with the odronextamab clinical efficacy or safety, trial design, labeling or manufacturing. Odronextamab (REGN1979), which targets CD20 and CD3, is a hinge-stabilized human bispecific antibody based on an IgG4 isotype modified to reduce Fc binding. Regulatoryreviewof odronextamab remains ongoing by theEuropean Medicines Agency for the treatment of R/R DLBCL and R/R FL. https://lnkd.in/emNcZDCD

15

Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) together with a New Drug Application (NDA) seeking the approval of RYBREVANT® (amivantamab-vmjw) in combination with lazertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution mutations, as detected by an FDA-approved test. Based on the Phase 3 MARIPOSA study, this marks the third submission from the RYBREVANT® clinical development program in four months, following sBLA submissions for MARIPOSA-2 and PAPILLON.

2

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company's Biologics License Application for zolbetuximab, a first-in-class investigational Claudin 18.2-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in the U.S. for these patients. The FDA has set a target action date of January 12, 2024. The FDA reviewed the application under its Real-Time Oncology Review program, which aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.#mabs https://lnkd.in/eTvgF63G

23

1 Comment

FDA Accepts BeiGene's SNDA for Fifth BRUKINSA IndicationBeiGene's sNDA for BRUKINSA in combination with obinutuzumab has been accepted by the FDA for treating relapsed or refractory follicular lymphoma. The Phase II ROSEWOOD study demonstrated superior efficacy of the combination therapy. Regulatory reviews are underway in multiple countries, reflecting BeiGene's commitment to advancing FL treatment globally. Excitement builds for potential approval.FDA Accepts BeiGene's SNDA for Fifth BRUKINSA Indication. For more captivating news and updates in the pharmaceutical industry,visit Pharmtales, your source for Today Pharma News.#pharma #pharmaceutical #latestnewstoday #pharmtales #pharmaceuticals https://lnkd.in/d9AqjbXD

2

On March 7, 2024, AstraZeneca registered the Phase III clinical trial of the novel drug AZD0901 (CMG901), a Claudin18.2 ADC, for the second-line or higher treatment of advanced or metastatic gastric cancer on the Drug Clinical Trial Registration and Information Publicity Platform website.In February 2024, Innovent Biologics registered the Phase III clinical trial of IBI343 for the treatment of Claudin18.2-positive, HER2-negative gastric cancer on the ClinicalTrials.gov website. This marks the first global Phase III clinical trial for a Claudin18.2 ADC.The catalytic moment for Claudin 18.2 ADC is approaching, bringing anticipation for breakthroughs in gastric cancer, especially pancreatic cancer. Currently, there are over ten investigational Claudin18.2 ADC drugs worldwide, with the majority developed by domestic innovative pharmaceutical companies. Leading the clinical progress are companies such as Innovent Biologics, Connoya, Lanova Medicines, Hengrui Medicine, and RemeGen. Among them, Innovent Biologics' IBI343 and Connoya's CMG901 have entered Phase III clinical trials. Foreign pharmaceutical companies tend to acquire Claudin 18.2 ADC through collaboration, such as AstraZeneca's introduction of Connoya's CMG901 and Turning Point Therapeutics' collaboration with Lanova Medicines to develop LM-302.If you look for any human APIs, pls contact with rebecca@xmfine.com.#APIs#Pharma#Pharmaceutical#Rawmaterials#Medical

🚀 Exciting News! Autolus Therapeutics Makes Strides in Adult B-Cell ALL Treatment Journey!🌟 Autolus Therapeutics plc has just submitted a Biologics License Application (BLA) to the U.S. FDA for obecabtagene autoleucel (obe-cel) - a cutting-edge CAR T cell therapy targeting relapsed/refractory (r/r) adult B-Cell Acute Lymphoblastic Leukemia (ALL).📊 The BLA, backed by compelling data from the pivotal Phase 2 FELIX study (presented at ASCO 2023), propels company forward in the pursuit of innovative treatment solutions.🌍 Global Impact: Autolus is set to submit a Marketing Authorization Application to the European Medicines Agency (EMA) in early 2024, signifying a significant leap towards EU approval.🤔Thoughts: 1. Big win for patients and potentially a safer treatment than Tecartus.2. Huge boost for UK life science strategy. 3. Rollercoaster ride for shareholders today. 4. Will GSK buy: strategic and political fit makes a lot of sense. What do you think?#autolus #gsk #cart #cellandgenetherapy #cgtcatapult #mergersandacquisitions

4

🚀 Exciting News in #Biotech! Autolus Therapeutics has just submitted its first Biologics License Application (BLA) to the US FDA for its groundbreaking therapy. This achievement is built on the compelling data presented at the 2023 ASCO Annual Meeting, with more updates needed at the upcoming ASH Meeting in San Diego on Saturday, December 9.📈 As a key player in the biotech industry, Autolus continues to push boundaries and set new standards in CAR-T therapy. Investors and analysts, this is a development you won't want to miss!🔗 For more details, check out the official press release 👇 #BiotechInnovation #InvestmentOpportunity #FDAApproval #MedicalAdvancements

Analysis of #FDA’s important #NDA and BLA applications in the first quarter of 2024In the first quarter of 2024, FDA's CDER (Center for Drug Evaluation and Research) and CBER (Center for Biologics Evaluation and Research) will review and approve numerous new drug applications.Below are the PDUFA dates (the popular name for the date when the FDA must respond to a new drug application or biologics license application) for 15 drugs of note, as well as NDAs and BLAs expiring in the first quarter of 2024.01 CosibelimabPDUFA date: January 3, 2024Developer: Checkpoint Therapeutics Inc/TG Therapeutics IncModality: anti-PD-L1 antibodyIndications: Metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCClinical Update: Cosibelimab clinical trials evaluated cosibelimab in patients with metastatic and locally advanced cSCC. In January 2022, Checkpoint announced that metastatic cSCC met its primary endpoint, with an objective response rate of 47.4% (95% CI: 36.0, 59.1). In June 2022, Checkpoint announced positive interim results for cosibelimab in locally advanced cSCC. The ORR of cosibelimab was 54.8% (95%CI: 36.0, 72.7).02 BerdazimerPDUFA date: January 5, 2024Developer: Novan IncMode: small molecules. Berdazimer is composed of two ingredients that promote the release of nitric oxide (NO): a NO donor, berdazimer sodium. A hydrogel that acts as a proton donor on the skin and promotes the controlled release of NO.Indications: Acne and molluscum contagiosumClinical Update: In the B-SIMPLE4 (Phase III) trial, 891 patients aged ≥6 months with 3-70 molluscum contagiosum lesions were randomly assigned to berdazimer gel or vehicle for 12 years. The complete clearance rate in the Berdazimer group was 37% (145/391) at week 12 and 60% (226/374) at week 24; the complete clearance rate in the vehicle group at week 12 was 20% (79/391). 390) and 46% (174/378) at 24 weeks.03 ZolbetuximabPDUFA date: January 12, 2024Developer: Astellas Pharma IncModality: Experimental monoclonal antibody targeting claudin-18 isoform 2Indications: Gastrointestinal adenocarcinoma and pancreatic tumorsClinical Update: Between June 21, 2018, and April 1, 2022, 565 patients were randomly assigned to receive zolbetuximab plus mFOLFOX6 (283 patients; zolbetuximab group) or placebo plus mFOLFOX6 (282 patients; placebo) Group). Treatment with zolbetuximab showed a significant reduction in the risk of disease progression or death compared with placebo (hazard ratio 0.75, 95% CI 0.60–0.94; p=0.0066). Median progression-free survival was 10.61 months (95% CI 8.90–12.48) in the zolbetuximab group and 8.67 months (8.21–10.28) in the placebo group. Treatment with zolbetuximab also showed a significant reduction in the risk of death compared with placebo (HR 0.75, 95% CI 0.60–0.94; p=0.0053).#newdrug