Original New Drug Application Approvals by US FDA (1-15 September 2024) | Multidisciplinary

New drug applications approved by US FDA as of 1-15 September 2024 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

TECENTRIQ HYBREZA

Active Ingredient(s): Atezolizumab And Hyaluronidase-tqjs
Strength: 125MG;2000UNITS PER ML
Dosage Form(s) / Route(s): Injectable;injection
Company: Genentech Inc
Approval Date: 12 September 2024
Submission Classification: NA
Indication(s): Indicated:

Non-Small Cell Lung Cancer (NSCLC)

as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test.
for the first-line treatment of adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an FDAapproved test, with no EGFR or ALK genomic tumor aberrations.
in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
in combination with paclitaxel protein-bound and carboplatin for the firstline treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.
for the treatment of adult patients with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ HYBREZA.

Small Cell Lung Cancer (SCLC)

in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Hepatocellular Carcinoma (HCC)

in combination with bevacizumab for the treatment of adult patients with unresectable or metastatic HCC who have not received prior systemic therapy.

Melanoma

in combination with cobimetinib and vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma as determined by an FDA-approved test.

Alveolar Soft Part Sarcoma (ASPS)

for the treatment of adult patients with unresectable or metastatic ASPS.

Approved Label: 12 September 2024 (PDF)

EBGLYSS

Active Ingredient(s): Lebrikizumab-lbkz
Strength: 250MG/2ML
Dosage Form(s) / Route(s): Injectable;injection
Company: Eli Lilly And Co
Approval Date: 13 September 2024
Submission Classification: NA
Indication(s): Indicated for the treatment of adult and pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids.
Approved Label: 13 September 2024 (PDF)

OCREVUS ZUNOVO

Active Ingredient(s): Ocrelizumab And Hyaluronidase-ocsq
Strength: 40MG;1000UNITS PER ML
Dosage Form(s) / Route(s): Injectable;injection
Company: Genentech Inc
Approval Date: 13 September 2024
Submission Classification: NA
Indication(s): Indicated for the treatment of:

Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
Primary progressive MS, in adults

Approved Label: 13 September 2024 (PDF)