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FDA Approves First Interchangeable Biosimilar to Pertuzumab for HER2-Positive Breast Cancer

Drug ApprovalMonoclonal Antibody
  • The FDA has approved pertuzumab-dpzb (Poherdy) as the first interchangeable biosimilar to pertuzumab (Perjeta), providing a new treatment option for HER2-positive breast cancer patients.
  • The biosimilar is approved for the same indications as the reference product, including metastatic and early-stage breast cancer treatment in combination with trastuzumab and chemotherapy.
  • As an interchangeable biosimilar, pertuzumab-dpzb may be substituted for the reference product without prescriber consultation, potentially enhancing therapeutic accessibility and reducing drug costs.
  • The approval was supported by comprehensive analytical, pharmacokinetic, immunogenicity, and clinical data demonstrating no clinically meaningful differences in safety, purity, and potency compared to pertuzumab.

A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer

NCT05346224Active, Not RecruitingPhase 3
Shanghai Henlius Biotech
Posted 4/25/2022

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer

NCT00567190CompletedPhase 3
Genentech, Inc.
Posted 2/12/2008

Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects

NCT04411550CompletedPhase 1
Shanghai Henlius Biotech
Posted 7/1/2020

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer

NCT01358877CompletedNot Applicable
Hoffmann-La Roche
Posted 11/8/2011

FDA Approves Kura Oncology's Komzifti for NPM1-Mutated AML with Competitive Safety Advantage

Drug ApprovalOncology
  • The FDA approved Kura Oncology's once-daily pill Komzifti (ziftomenib) for treating relapsed/refractory acute myeloid leukemia with NPM1 mutations, affecting about 30% of AML cases.
  • Komzifti gains a competitive safety edge over Syndax's recently approved Revuforj by avoiding a boxed warning for cardiac side effects, carrying only a regular warning for QTc prolongation.
  • The drug will be priced at $48,500 for a one-month supply and is expected to generate $1.32 billion in annual sales by 2031 according to analyst projections.

Ingenus Pharmaceuticals Launches First Generic Version of Premarin Tablets After FDA Approval

Drug Approval
  • Ingenus Pharmaceuticals received FDA approval and launched Conjugated Estrogens Tablets, USP, marking the first generic equivalent to Premarin Tablets available in the United States.
  • The generic hormone therapy is immediately available nationwide in all five FDA-approved strengths for treating moderate to severe menopausal vasomotor symptoms and preventing postmenopausal osteoporosis.
  • This milestone represents a significant advancement in expanding patient access to affordable hormone replacement therapy for women's health conditions.

NHS Approves Glofitamab for Earlier Treatment of Aggressive Blood Cancer

Monoclonal AntibodyDrug Approval
  • The NHS has approved glofitamab (Columvi) for around 300 patients annually with relapsed or refractory diffuse large B-cell lymphoma after just one previous treatment, expanding access from the previous requirement of two failed treatments.
  • Clinical trial data shows nearly 60% of patients achieved complete remission with glofitamab plus chemotherapy, with 54% survival at two years compared to 34% with standard treatment.
  • The drug will be available immediately through the NHS Cancer Drugs Fund, representing a significant advancement for patients with this aggressive form of non-Hodgkin lymphoma that affects approximately 5,500 people annually in England.

Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT03399799Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/16/2017

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04634552RecruitingPhase 2
Janssen Research & Development, LLC
Posted 2/1/2021

Vietnam Approves Russian Pembrolizumab Biosimilar for Cancer Treatment

Monoclonal AntibodyDrug Approval
  • Vietnam's Ministry of Health has approved Pembroria, a Russian-produced pembrolizumab biosimilar, for treating over 14 types of cancer including melanoma, lung, breast, and colorectal cancers.
  • The drug, manufactured by Russia's Limited Liability "PK-137" and containing 100 mg pembrolizumab per 4 ml vial, expands access to advanced immunotherapy treatments for Vietnamese patients.
  • Each treatment cycle costs approximately $1,400 (VND36 million for two vials) and is not yet covered by Vietnam's health insurance system.
  • The approval follows Vietnam-Russia health cooperation discussions in September, with both countries agreeing to strengthen collaboration in cancer vaccine research and technology transfer.

Elite Pharmaceuticals Secures FDA Approval for Generic Ropinirole Extended-Release Tablets for Parkinson's Disease

Drug Approval
  • Elite Pharmaceuticals received FDA approval for a generic version of Requip XL (Ropinirole Extended-Release Tablets USP) in five strengths for treating Parkinson's disease symptoms.
  • The approved generic will be marketed under Elite's own Elite Laboratories label, targeting a market with $10 million in annual U.S. sales.
  • Ropinirole functions as a non-ergoline dopamine agonist, representing Elite's continued focus on developing niche generic pharmaceutical products.

Zydus Lifesciences Secures First Drug Approval in China for Venlafaxine ER Capsules

Drug Approval
  • Zydus Lifesciences received its first drug approval from China's National Medical Products Administration (NMPA) for Venlafaxine Extended-Release Capsules in 75 mg and 150 mg strengths.
  • The approved medication is indicated for treating Major Depressive Disorder, Generalised Anxiety Disorder, Social Anxiety Disorder, and Panic Disorder by restoring serotonin and norepinephrine balance.
  • Production will take place at Zydus' manufacturing facility in Moraiya, Ahmedabad, marking a significant milestone in the company's expansion into the Chinese pharmaceutical market.

Granules Life Sciences Receives First US FDA Approval for Hyderabad Manufacturing Facility

Drug Approval
  • Granules Life Sciences, a wholly owned subsidiary of Granules India, has secured its first US FDA approval for its Hyderabad manufacturing facility following a pre-approval inspection conducted in July-August 2025.
  • The FDA approval marks a significant milestone for Granules India as it expands its finished dosage manufacturing capabilities, with the company planning to launch the approved product in the US market soon.
  • The new approval will strengthen market share and support business continuity through multi-site manufacturing, as the same product is already approved and manufactured at Granules' Gagillapur facility.
  • Additional products have been filed from the Hyderabad site, with the company expecting further FDA approvals following necessary audits.

Geneseeq's PanTRKare™ Receives NMPA Approval as China's First NGS-Based Pan-Solid Tumor Companion Diagnostic for NTRK Gene Fusions

Precision MedicineDrug ApprovalTargeted TherapyOncology
  • Geneseeq Technology Inc. has received NMPA approval for PanTRKare™, China's first next-generation sequencing-based pan-solid tumor companion diagnostic test for detecting NTRK1/2/3 gene fusions.
  • The assay was validated through a comprehensive multi-center clinical study involving seven leading hospitals, 33 tumor types, and more than 2,400 clinical samples, successfully detecting over 200 unique NTRK fusion variants.
  • PanTRKare™ is approved as a companion diagnostic test for Roche's ROZLYTREK® (entrectinib), addressing the clinical need to identify patients with rare NTRK gene fusions who can benefit from targeted TRK inhibitor therapy.
  • Clinical bridging studies demonstrated high concordance with ROZLYTREK® testing results and comparable objective response rates among NTRK fusion-positive patients, establishing the test's clinical utility for precision medicine.

Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

NCT02568267Active, Not RecruitingPhase 2
Hoffmann-La Roche
Posted 11/19/2015

Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations.

NCT02097810CompletedPhase 1
Hoffmann-La Roche
Posted 7/28/2014

Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options

NCT02650401Active, Not RecruitingPhase 1
Hoffmann-La Roche
Posted 5/3/2016

UK High Court Clears Path for Alvotech's Eylea Biosimilar Manufacturing Ahead of Patent Expiry

Drug Approval
  • The UK High Court rejected Regeneron and Bayer's injunction request against Alvotech's manufacturing of AVT06, a biosimilar to Eylea (aflibercept), allowing continued production at the company's UK contract manufacturing organization.
  • The court decision supports commercial launches of AVT06 in the European Economic Area, UK and other countries after the Supplementary Protection Certificate expiry on November 23, 2025.
  • AVT06 has already received regulatory approval from the European Commission on August 21, 2025, and the UK MHRA on August 28, 2025, with dossiers under review in multiple countries including the United States.
  • The ruling reinforces the SPC waiver system that allows biosimilar manufacturers to stockpile products six months before patent expiry, supporting market entry and patient access to cost-effective biologics.

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