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FDA approval of a new pediatric indication for BESPONSA®

Pfizer Oncology is proud to announce the FDA approval of a new pediatric indication for BESPONSA® (inotuzumab ozogamicin). The following information is available for review: ·       Full Prescribing Information Including Boxed Warning

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TAGRISSO (osimertinib) with the addition of chemotherapy approved in the US for patients with EGFR-mutated advanced lung cancer

AstraZeneca’s TAGRISSO® (osimertinib) with the addition of chemotherapy has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The approval following a Priority Review by the Food and Drug Administration (FDA) was based on the results from the FLAURA2 Phase III trial […]

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Truqap (capivasertib) plus Faslodex approved in the US for patients with advanced HR-positive breast cancer

First-in-class AKT inhibitor has potential to reshape treatment for breast cancer patients with specific biomarker alterations (PIK3CA, AKT1 or PTEN). Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in the biomarker-altered population. AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the […]

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Takeda announces that the US Food and Drug Administration has approved FRUZAQLA™ (fruquintinib), an oral therapy for adult patients with previously treated metastatic colorectal cancer (mCRC).1,*

*FRUZAQLA is a kinase inhibitor indicated for the treatment of adult patients with mCRC who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy.1 CRC is the 4th most common cancer in the US, and up to 50% of patients with CRC will […]

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Bristol Myers Squibb announces FDA approval for Opdivo® (nivolumab) as Adjuvant Treatment for Eligible Patients with Completely Resected Stage IIB or Stage IIC Melanoma

Bristol Myers Squibb (NYSE: BMY) recently announced that Opdivo®(nivolumab) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma, expanding upon the existing adjuvant indication for Opdivo and further reinforcing the company’s legacy of providing treatment options for […]

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New FDA Approved Indication for LYNPARZA® (olaparib)

AstraZeneca recently announced that the US Food and Drug Administration (FDA) has approved a new indication for LYNPARZA® (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA. […]

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Seagen Announces FDA Accelerated Approval of TUKYSA®

Top of Form Seagen Announces FDA Accelerated Approval of TUKYSA® (tucatinib) in Combination with Trastuzumab for People with Previously Treated RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer – First FDA-approved treatment in HER2-positive metastatic colorectal cancer – – Combination regimen is approved for use in the second-line treatment setting and beyond – BOTHELL, Wash.–(BUSINESS WIRE)– Seagen Inc. (Nasdaq: […]

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New FDA indication for IMFINZI® (durvalumab1,2 )

AstraZeneca recently announced that the US Food and Drug Administration (FDA) has approved a new indication for IMFINZI® (durvalumab1,2 ), in combination with IMJUDO® (tremelimumab-actl), for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). 1,2 This approval is based on results from the HIMALAYA trial, a Phase III, global, randomized, open-label, multicenter study […]

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New FDA Approval for IMFINZI® (durvalumab)

The US Food and Drug Administration (FDA) has approved a new indication for IMFINZI® (durvalumab), in combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).1 BTCs comprise a heterogeneous group of rare cancers, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer, that account for […]

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FDA Approval of Imbruvica

On August 24, 2022, the Food and Drug Administration approved ibrutinib (Imbruvica, Pharmacyclics LLC) for pediatric patients ≥ 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension. For more information, read the FDA Announcement or Press Release.

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