Remove 2017 Remove Chemotherapy Remove FDA
article thumbnail

FDA looks at pulling speedy approvals for three cancer drugs

pharmaphorum

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies.

FDA 90
article thumbnail

BMS finally gets FDA OK for liso-cel, sets $410k launch price

pharmaphorum

Bristol-Myers Squibb finally has FDA approval for its CAR-T therapy liso-cel, which has been cleared by the US regulator as Breyanzi for certain forms of large B-cell lymphoma. DLBCL is the most common type of NHL in adults, accounting for around a third of the 77,000 new cases diagnosed in the US, according to the FDA.

FDA 111
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Gilead scores US approval for breast cancer drug that wowed ESMO

pharmaphorum

Gilead’s $21 billion purchase of Immunomedics and its potential blockbuster Trodelvy continues to pay off, as the drug has now been approved by the FDA for triple-negative breast cancer. . months in patients treated with chemotherapy. California-based Gilead had already announced its strong intentions in oncology in 2017 with its $11.9

article thumbnail

Kite cues up first EMA okay for mantle cell lymphoma CAR-T

pharmaphorum

MCL is generally treated first with chemotherapy, and patients whose disease progresses despite that can then receive stem cell transplantation or BTK inhibitor drugs like Johnson & Johnson/AbbVie’s Imbruvica (ibrutinib) and AstraZeneca’s Calquence (acalabrutinib). billion acquisition of Kite in 2017.

article thumbnail

Merck pulls Keytruda’s FDA nod for third-line stomach cancer

pharmaphorum

The decision comes after FDA advisors voted six to two in April that Keytruda (pembrolizumab) should not stay on the market as a treatment option for patients with PD-L1-expressing gastric or gastroesophageal junction (GEJ) adenocarcinoma in patients who have received two or more earlier lines of therapy.

FDA 52
article thumbnail

Merck & Co axes Keytruda lung cancer niche amid FDA crackdown

pharmaphorum

Merck & Co has voluntarily withdrawn its Keytruda immunotherapy from a lung cancer niche in the US, amid a crackdown by the FDA on drugs approved without the required post-marketing data. Merck & Co said it had withdrawn the indication after consultation with the FDA and is working to complete the process over the coming weeks.

FDA 59
article thumbnail

The top 5 pharma M&A deals of 2020

pharmaphorum

California-based Gilead announced its strong intentions in oncology in 2017 with its $11.9 months in patients treated with chemotherapy. Sanofi’s acquisition builds on a partnership to develop central nervous system drugs that began in late 2017. billion (see below). months, compared with 6.7 Johnson and Johnson & Momenta.