Larotrectinib Sulfate and Quetiapine Fumarate

• Generic Name: larotrectinib
• Dosage Forms: n.a.
• Other Brand Names: Vitrakvi

Treatment of solid tumors harboring an NTRK fusion (without a known acquired mutation for resistance) in patients who have metastatic disease or may experience severe morbidity following surgical resection and whose disease progressed following prior therapy or those who are not candidates for other treatment options (designated an orphan drug by FDA for these cancers).

Accelerated approval based on overall response rate and duration of response. Continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.

Confirmation of the presence of NTRK fusion is necessary prior to initiation of therapy. In clinical studies, NTRK fusion status of tumor specimens was determined by fluorescence in situ hybridization (FISH), reverse transcription-polymerase chain reaction (RT-PCR), or next-generation sequencing (NGS).

• Generic Name: quetiapine
• Dosage Forms: n.a.
• Other Brand Names: Seroquel, Seroquel XR

Symptomatic management of schizophrenia.

Management (alone or in combination with lithium or divalproex sodium) of acute manic episodes associated with bipolar I disorder.