CASTRES, France, July 26, 2024 /PRNewswire/ -- Pierre Fabre Laboratories announced today that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the approval of BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation. The positive opinion will now be submitted to the European Commission (EC) with a decision on EU marketing authorisation (MA) expected later this year.
Eric Ducournau, Chief Executive Officer, Pierre Fabre Laboratories said: "The positive CHMP opinion marks a pivotal step in our commitment to delivering an additional effective targeted treatment option for patients with advanced NSCLC with a BRAFV600E mutation, who at present have limited treatment options. We look forward to the European Commission's decision to make BRAFTOVI® + MEKTOVI® available to non-small cell lung cancer patients in Europe."
The CHMP positive opinion is supported by data from the global, open-label, multicentre, non-randomised Phase II PHAROS trial, which included 98 patients from 56 study centres across 5 countries.[1]
At primary analysis (cut-off date: September 22, 2022), the primary endpoint of the trial (objective response rate [ORR] determined by independent radiology review [IRR]) was met. The PHAROS trial showed that in patients with advanced NSCLC with a BRAFV600E mutation, BRAFTOVI® and MEKTOVI® provided a meaningful clinical benefit with an ORR of 75% (95% CI: 62, 85) in treatment naïve patients (n=59), with 59% of them maintaining their response for at least 12 months. For those patients who had received prior therapy (n=39), the ORR was 46% (95% CI: 30, 63), with 33% maintaining their response for at least 12 months.[1]
CONTACT: Laurence MARCHAL laurence.marchal@pierre-fabre.com
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
Pierre Fabre Laboratories receives CHMP positive opinion for BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation
"Anything. This is the mic for that."
SINGAPORE, Oct. 18, 2024 /PRNewswire/ -- They say that if you've heard music, you are most likely to have heard the MD 421, a Sennheiser microphone featured in countless award-winning performances and productions over the past six decades. Now Sennheiser launches the MD 421 Kompakt, an incredibly versatile microphone that delivers the same legendary performance, but in a truly multipurpose package — including a completely redesigned mounting clip. The MD 421 Kompakt features a cardioid pick-up pattern and remarkable dynamic range, delivering crystal-clear sound reproduction in live sound and recording applications.
"The MD 421 is an incredibly versatile microphone. Since its inception in 1960, it excelled as a studio and a vocal microphone, but was also used a lot in broadcasting, where it appeared with many celebrities of the time. Today, its successor, the MD 421-II, which launched in 1998, is an all-rounder for multipurpose miking and well known to be used on drums, guitar cabs and horns," says Bertram Zimmermann, Manager Live Sound & Studio. "It works on anything, capturing the sound source with precision, detail, and rich sound."
"With the MD 421 Kompakt, we're offering the same legendary sound and ability to handle high sound pressure levels, but with an incredibly compact form factor," adds Jimmy Landry, Category Marketing Manager MI.
Compact design, same great sound
To give the MD 421 microphone its compact dimensions all while retaining the large-diaphragm capsule and the pristine sound of the much bigger MD 421-II, the bass roll-off switch was eliminated. "While this feature made total sense when the MD 421 was designed, and was carried over to the MD 421-II, this functionality has long since been taken over by mixing desks and DAWs," says Zimmermann. "Omitting the switch allowed us to create a relatively small microphone body, making the Kompakt an ideal tom mic, but also a versatile tool for any recording or live application."
Sound-wise, the MD 421 Kompakt delivers the same detailed and authentic reproduction of the sound source that the MD 421 and MD 421-II have become famous for. The microphone's frequency response of 30 Hz to 17 kHz faithfully reproduces both high and low frequencies, with a bass tube ensuring an accurate and extended low-end response. The sound is rich and full-bodied, and incredibly clear and detailed at the same time.
The MD 421 Kompakt also provides effective feedback rejection, and is able to handle exceptionally high sound pressure levels even in demanding environments.
New clip
The clip of the MD 421 Kompakt has been entirely redesigned, and is now part of the microphone housing for easy, worry-free mounting. "The clip is the one thing that users have always criticised," remarks Landry. "The new clip is an integral part of the mic, and the optional drum clamp securely screws into this clip, ensuring fail-safe mounting on drums."
Rugged all around
The MD 421 Kompakt is designed to withstand the rigours of touring and heavy studio use. It features a rugged frame with a stainless-steel basket, and a gold-plated XLR-3 connector. A protective inner chassis enclosure reduces the exposure to dust and humidity.
Availability and pricing
The MD 421 Kompakt is available now for EUR 279 (MSRP), the version for drums comes complete with an MZH drum clamp and retails at EUR 299 (MSRP). The MZH drum clamp included with the drum version is also available separately for EUR 19 (MSRP). The MD 421-II will remain in the portfolio alongside the MD 421 Kompakt.
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
Sennheiser launches the MD 421 Kompakt - an appropriately named, compact version of legendary all-rounders, the MD 421 and MD 421-II
