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FDA Approvals, News & Updates
FDA Approvals, News & Updates
Tafinlar plus Mekinist Combination Approved for Pediatric Low-Grade Glioma with BRAFᵛ⁶⁰⁰ᴱ Mutation
FDA Approvals, News & Updates
,
Head and Neck Cancer
April 2023, Vol 14, No 2
On
March 16, 2023
, the FDA approved dabrafenib (Tafinlar; Novartis) in combination with trametinib (Mekinist; Novartis) for the treatment of pediatric patients aged ≥1 year with low-grade glioma that harbors a
BRAF
V600E
mutation and who require systemic therapy.
Read Article
FDA Expands Indication for Verzenio as Adjuvant Treatment for HR-Positive, HER2-Negative, Early Breast Cancer
FDA Approvals, News & Updates
,
Breast Cancer
April 2023, Vol 14, No 2
On
March 3, 2023
, the FDA approved abemaciclib (Verzenio; Eli Lilly) plus endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive,
HER2
-negative, node-positive, early breast cancer at high risk for recurrence.
Read Article
Jemperli Receives Regular FDA Approval for Advanced Endometrial Cancer
FDA Approvals, News & Updates
,
Gynecologic Cancer
,
Endometrial Cancer
April 2023, Vol 14, No 2
On
February 9, 2023
, the FDA approved dostarlimab-gxly (Jemperli; GlaxoSmithKline) for the treatment of adult patients with mismatch repair-deficient, recurrent or advanced endometrial cancer, as determined by an FDA-approved test, whose disease has progressed on or following a previous platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation.
Read Article
Trodelvy Now Approved for Pretreated Patients with HR-Positive, HER2-Negative Breast Cancer
FDA Approvals, News & Updates
,
Breast Cancer
April 2023, Vol 14, No 2
On
February 3, 2023
, the FDA approved sacituzumab govitecan-hziy (Trodelvy; Gilead Sciences/Immunomedics) for the treatment of patients with unresectable, locally advanced or metastatic hormone receptor (HR)-positive,
HER2
-negative (immunohistochemistry [IHC] 0, IHC 1+, or IHC 2+ with a negative in situ hybridization test) breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting.
Read Article
Keytruda Received FDA Approval for Adjuvant Treatment of NSCLC
FDA Approvals, News & Updates
,
Lung Cancer
February 2023, Vol 14, No 1
On
January 26, 2023
, the FDA approved pembrolizumab (Keytruda; Merck), a PD-1 inhibitor, as monotherapy for adjuvant treatment of patients with stage IB (T2a ≥4 cm), II, or IIIA non–small-cell lung cancer (NSCLC), after resection and platinum-based chemotherapy.
Read Article
Orserdu FDA Approved for ER-Positive, Advanced or Metastatic Breast Cancer with ESR1 Mutation
FDA Approvals, News & Updates
,
Breast Cancer
February 2023, Vol 14, No 1
On
January 27, 2023
, the FDA approved elacestrant (Orserdu; Stemline Therapeutics), an estrogen receptor (ER) antagonist, for the treatment of postmenopausal women or adult men with ER-positive,
HER2
-negative advanced or metastatic breast cancer and an
ESR1
mutation whose disease progressed after ≥1 line of endocrine therapy.
Read Article
Adstiladrin, First Adenoviral Vector–Based Gene Therapy, FDA Approved for High-Risk Non–Muscle Invasive Bladder Cancer
FDA Approvals, News & Updates
,
Bladder Cancer
,
Genitourinary Cancers
February 2023, Vol 14, No 1
On
December 22, 2022
, the FDA accelerated the approval of mosunetuzumab-axgb (Lunsumio; Genentech), a bispecific CD20-directed CD3 T-cell engager, for adults with relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy. The FDA granted this indication breakthrough therapy and orphan drug designations.
Read Article
Krazati Receives Accelerated FDA Approval for NSCLC with KRASᴳ¹²ᶜ Mutation
FDA Approvals, News & Updates
,
Lung Cancer
February 2023, Vol 14, No 1
On
December 12, 2022
, the FDA accelerated the approval of adagrasib (Krazati; Mirati Therapeutics), a RAS GTPase inhibitor, for adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) and
KRAS
G12C
mutation (as determined by an FDA-approved test) who have received at least 1 systemic therapy.
Read Article
Tecentriq Now FDA Approved for Treatment of Alveolar Soft-Part Sarcoma
FDA Approvals, News & Updates
February 2023, Vol 14, No 1
On
December 9, 2022
, the FDA approved atezolizumab (Tecentriq; Genentech), a PD-L1 inhibitor, for patients aged ≥2 years with unresectable or metastatic alveolar soft-part sarcoma (ASPS), a type of soft-tissue sarcoma.
Read Article
Tukysa, in Combination with Trastuzumab, Now FDA Approved for HER2-Positive, Unresectable or Metastatic Colorectal Cancer
FDA Approvals, News & Updates
,
Colorectal Cancer
February 2023, Vol 14, No 1
On
January 19, 2023
, the FDA accelerated the approval of tucatinib (Tukysa; Seagen), a Bruton tyrosine kinase inhibitor, in combination with trastuzumab (Herceptin), a HER2/
neu
receptor agonist, for the treatment of
RAS
wild-type,
HER2
-positive, unresectable or metastatic colorectal cancer (CRC) that progressed after fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies.
Read Article
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Home
Issues
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Personalized Medicine
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